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 2018-01-25 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 04784596190 manufactured by Roche Diagnostics.
[98583491]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[98583492]
The customer received discrepant elecsys cmv igg assay (cmv igg) results for 1 patient sample on the cobas 8000 e 602 module serial number (b)(4). The initial (b)(6) result was (b)(6). On (b)(6) 2017 the patient notified the laboratory that a (b)(6) for (b)(6) was detected in another laboratory with a different sample. The (b)(6) was (b)(6) and (b)(6) was (b)(6) in the other laboratory. The methods that were used for testing in the other laboratory were not provided. On (b)(6) 2017 the customer tested the sample from (b)(6) 2017 that had been frozen and the (b)(6) result was (b)(6). On (b)(6) 2018 a new sample was collected and the (b)(6) result was (b)(6). On (b)(6) 2018 the customer sent the sample to another laboratory. The (b)(6) result was (b)(6) with the siemens method. The (b)(6) result was (b)(6) with the diasorin method. The erroneous results were reported outside of the laboratory. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[134201782]
The sample from the patient was submitted for investigation and the customer's negative result was confirmed. Cmv igm: 0. 438 coi (nonreact) cmv igg: 0. 15 u/ml (< test) the patient sample was investigated further by the recomline method. The cmv igm result was reactive. This testing showed the positive recomline cmv igg results were due to reactivity towards pp65, a cmv antigen that is not contained in the elecsys cmv igg assay. Reactivity against other antigens could also have been detected by the recomline assay. The epitope required for detection in the elecsys cmv igg assay was determined to not be sufficiently present in the sample. The investigation was unable to find a definitive root cause. Per product labeling for the assay, discrepant negative results can occur in rare cases due to this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00248 |
| MDR Report Key | 7219814 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-25 |
| Date of Report | 2018-02-27 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2018-01-13 |
| Date Added to Maude | 2018-01-25 |
| 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 | 2018-01-25 |
| Model Number | NA |
| Catalog Number | 04784596190 |
| Lot Number | 212196 |
| ID Number | NA |
| Device Expiration Date | 2018-02-01 |
| 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 | 2018-01-25 |