MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-03-30 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS manufactured by Roche Diagnostics.
[41567328]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41567329]
The customer questioned results for 21 patients tested for igm antibodies to cytomegalovirus (cmv igm) and igg antibodies to cytomegalovirus (cmv igg). Erroneous cmv igm or cmv igg results were identified for 14 patients. The erroneous results for were reported outside of the laboratory. This medwatch will cover cmv igg. Refer to medwatch with patient identifier (b)(6) for information on the cmv igm erroneous results. Patient 1 initial cmv igm result from the e601 analyzer was 0. 386 coi (negative). The repeat result from the mini vidas analyzer was 1. 88 (positive) and the repeat result from the architect i 1000 was 1. 93 (positive). Patient 1 initial cmv igg result from the e601 analyzer was <0. 250 au/ml (negative). The sample was repeated on an architect i 1000 and the result was 19. 6 (positive). The cmv igg result from the mini vidas method was <4. 00 ua/ml (negative). On (b)(6) 2016 a new sample was obtained from patient 1 and the initial cmv igm result from the e601 analyzer was 0. 170 coi (negative). The sample was repeated on an architect i 1000 and the result was 76 (positive). The cmv igm result from the mini vidas method was 0. 120 (negative). The initial cmv igg result from the e601 analyzer was 16. 4 au/ml (positive). The sample was repeated on an architect i 1000 and the result was 0. 390 (negative). The cmv igg result from the mini vidas method was 9 ua/ml (positive). On (b)(6) 2016 patient 2 initial cmv igm result from the e601 analyzer was 0. 657 coi (negative). The repeat from the mini vidas analyzer was 1. 83 (positive). On (b)(6) 2016 patient 3 initial cmv igm result from the e601 analyzer was 0. 534 coi (negative). The result from the mini vidas instrument was 1. 280 (positive). The result from the architect i 1000 was positive; the actual result was not provided. On an unknown date patient 4 initial cmv igg initial result from the e601 analyzer was 1. 52 au/ml (positive). The repeat result from the architect i 1000 was 4. 3 (negative). On an unknown date patient 5 initial cmv igm initial result from the e601 analyzer was 0. 281 coi (negative). The repeat result from the architect i 1000 was 2. 09 (positive). The repeat result from the mini vidas analyzer was 1. 32 (positive). On an unknown date patient 6 initial cmv igm initial result from the e601 analyzer was 0. 644 coi (negative). The repeat result from the architect i 1000 was 2. 09 (positive). The repeat result from the mini vidas analyzer was 1. 32 (positive). On an unknown date patient 7 initial cmv igm initial result from the e601 analyzer was 0. 381 coi (negative). The repeat result from the architect i 1000 was 1. 51 (positive). The repeat result from the mini vidas analyzer was 1. 21 (positive). On an unknown date patient 8 initial cmv igm initial result from the e601 analyzer was 0. 192 coi (negative). The repeat result from the architect i 1000 was 2. 56 (positive). The repeat result from the mini vidas analyzer was 0. 08 (negative). On an unknown date patient 9 initial cmv igm initial result from the e601 analyzer was 0. 35 coi (negative). The repeat result from the architect i 1000 was 0. 91 (positive). The repeat result from the mini vidas analyzer was 1. 33 (positive). On an unknown date patient 10 initial cmv igm initial result from the e601 analyzer was 0. 364 coi (negative). The repeat result from the architect i 1000 was 5. 42 (positive). The repeat result from the mini vidas analyzer was 1. 08 (positive). On an unknown date patient 11 initial cmv igm initial result from the e601 analyzer was 0. 219 coi (negative). The repeat result from the architect i 1000 was 0. 93 (positive). The repeat result from the mini vidas analyzer was 0. 17 (negative). On an unknown date patient 12 initial cmv igm initial result from the e601 analyzer was 0. 045 coi (negative). The repeat result from the architect i 1000 was 3. 25 (positive). The repeat result from the mini vidas analyzer was 0. 38 (negative). On an unknown date patient 13 initial cmv igm initial result from the e601 analyzer was 0. 323 coi (negative). The repeat result from the architect i 1000 was 1. 07 (positive). The repeat result from the mini vidas analyzer was 0. 9 (positive). On an unknown date patient 14 initial cmv igm initial result from the e601 analyzer was 0. 344 coi (negative). The repeat result from the architect i 1000 was 1. 02 (positive). The repeat result from the mini vidas analyzer was 0. 07 (negative). It was noted that a primary infection was missed for patient 1 & 3 due to the negative cmv igm results, however, no adverse event occurred. Patient 2 was not adversely affected. No adverse event was reported for patients 4 through 14. The e601 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[48202910]
The samples for patient 1 from (b)(6) 2015 and (b)(6) 2016 were submitted for investigation. The results from the customer were confirmed during the investigation. The samples were tested by the roche method and the mikrogen recomline method. The roche results and recomline results were comparable. Both the roche assay and the recomline assays do not detect significant cmv-specific igm titers in the samples. For this patient, a seroconversion for igm was not detected. Missing the igm seroconversion of a patient with 2 independent assays at the same time is rare but cannot be excluded for this patient. The sample for patient 2 from (b)(6) 2016 was submitted for investigation. The samples were tested by the roche method and the mikrogen recomline method. The customer results could not be confirmed during the investigation. Cmv-specific igg antibodies were detected in both the roche cmv igg assay and the recomline cmv igg assay and found to be of high avidity. The high avidity of the detected igg antibodies indicates a remote infection with cmv. When samples are obtained during the declining phase of the igm response, assays from different manufacturers are likely to produce discrepant results; however, a reliable diagnosis of the cmv status can be obtained by assessing the igg status in combination with the igg avidity. A general decline of the cmv igm results was not confirmed. Internal quality assurance prior to product release and real time monitoring following product release guarantee constant performance. Comparative measurements minimize performance variance between different lots.
Patient Sequence No: 1, Text Type: N, H10
[50750865]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00377 |
| MDR Report Key | 5534903 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-30 |
| Date of Report | 2016-07-21 |
| Date of Event | 2015-10-26 |
| Date Mfgr Received | 2016-03-09 |
| Date Added to Maude | 2016-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2016-03-30 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-30 |