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 2016-02-11 for CMV IGM, IGM ANTIBODIES TO CYTOMEGALOVIRUS manufactured by Roche Diagnostics.
[38087149]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[38087150]
The customer complained of erroneous negative results for 1 patient tested for igg antibodies to cytomegalovirus (cmv igg). Based on the data provided, erroneous results for igm antibodies to cytomegalovirus (cmv igm) were also identified. It is not known if erroneous results were reported outside of the laboratory. This medwatch will cover cmv igm. Refer to medwatch with patient identifier (b)(6) for information on the cmv igg erroneous results. The initial cmv igg result from the e602 analyzer was 0. 267 u/ml (negative). The initial cmv igm result from the e602 analyzer was 0. 694 coi (negative). The sample was tested by the diasorin method and the cmv igg result was 30. 8 u/ml (positive). The cmv igm result was 59. 6 u/ml (positive). The sample was tested by the biomerieux method and the cmv igg result was 9 u/ml (positive). A new sample was obtained on (b)(6) 2016 and the cmv igg result from the e602 analyzer was 0. 99 u/ml (indeterminate). The cmv igm result from the e602 analyzer was 0. 757 coi (indeterminate). On (b)(6) 2016 this sample was repeated on the e602 after recentrifugation and the cmv igm result was 0. 633 coi (negative). The sample was tested by the diasorin method and the cmv igg result was 48. 6 u/ml (positive). The cmv igm result was 47. 7 u/ml (positive). The sample was tested by the biomerieux method and the cmv igg result was 13 u/ml (positive). On (b)(6) 2016 a new sample was obtained and the cmv igg result from the e602 analyzer was 1. 23 u/ml (positive) and the cmv igm result was 0. 699 coi (negative). It is not known if an adverse event occurred. No adverse event was reported. The e602 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[39790837]
A new sample from the patient was obtained on (b)(6) 2016 and the cmv igm result was 0. 88 coi and the cmv igg result was 2. 48 u/ml. The patient samples from (b)(6) 2015 and (b)(6) 2016 were submitted for investigation along with a follow-up sample from (b)(6) 2016. The customer results were confirmed during the investigation. During the investigation all 3 samples showed negative results for cmv igm. The samples were also tested by mikrogen recomline and all 3 samples showed positive results which correspond to the results from the competitor methods mentioned in the original report. Based on the results of the investigation, the data suggest the patient may have suffered from a primary cmv infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00144 |
| MDR Report Key | 5431597 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-11 |
| Date of Report | 2016-03-01 |
| Date of Event | 2015-12-03 |
| Date Mfgr Received | 2016-01-26 |
| Date Added to Maude | 2016-02-11 |
| 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 |
| 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 IGM, IGM ANTIBODIES TO CYTOMEGALOVIRUS |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2016-02-11 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 18701700 |
| 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 | 2016-02-11 |