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 2017-06-08 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 04784596190 manufactured by Roche Diagnostics.
[77422146]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[77422147]
The customer received questionable high elecsys cmv igg assay and elecsys toxo igg immunoassay results for one patient sample on a cobas 8000 e 602 module (e602), serial number (b)(4). This medwatch is for the cmv igg results. Refer to medwatch with a1 patient identifier (b)(6) for the toxo igg results. All results were released to the physician. The cmv igg result from the e602 was >500 u/ml (reactive). The sample was tested using a diasorin reagent with a result of <5. 00 u/ml (non-reactive). The toxo igg result from the e602 was >650 iu/ml (reactive). The sample was tested using a diasorin reagent with a result of <3. 00 iu/ml (non-reactive). There was no allegation that an adverse event occurred. Samples were requested for further investigation; however, the customer preferred to send the samples to a reference laboratory for additional testing.
Patient Sequence No: 1, Text Type: D, B5
[117899091]
The customer sent the patient sample to a reference laboratory for analysis by elisa. Units of measure were not provided for the results. On (b)(6) 2017, the cmv igg result was 0. 38. The patient also had cmv-igm result of 0. 34 and a cmv-igg avidity result of "negative. " no cmv-specific antibodies were detected. The customer also obtained a questionable result for one additional patient sample (patient b, female, (b)(6)) using the elecsys cmv igg assay on the e602. The results were released outside of the laboratory. On (b)(6) 2017, the initial result for patient b was 7. 70 u/ml (reactive). On (b)(6) 2017, the sample was tested using a diasorin reagent with a result of 6. 45 u/ml (non-reactive). On an unspecified date, the sample was tested using an "elisapks medac" with a result of "non-reactive". There was no allegation that an adverse event occurred for patient b. Investigation activities are ongoing. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120158652]
Calibration signals were lower than expected and the laboratory staff does not calibrate the instrument frequently. Quality controls were acceptable, with periodic high signal drift. No samples were received for investigation for cmv igg. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01173 |
| MDR Report Key | 6621491 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-08 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-03-28 |
| Date Mfgr Received | 2017-05-19 |
| Date Added to Maude | 2017-06-08 |
| 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 | 2017-06-08 |
| Model Number | NA |
| Catalog Number | 04784596190 |
| Lot Number | 174473 |
| 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 | 2017-06-08 |