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 2016-05-20 for IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) 04784618190 manufactured by Roche Diagnostics.
[45596467]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[45596468]
The customer stated that they received erroneous results for two patient samples tested for igm antibodies to cytomegalovirus (cmv igm) on an e601 analyzer. It was asked, but it is not known if the erroneous results were reported outside of the laboratory. The first sample initially resulted as 0. 448 coi (non-reactive) on the e601 analyzer. The sample was repeated at a different laboratory on an abbott architect analyzer on (b)(6) 2016, resulting as 1. 90 ratio (positive). The sample was also repeated on the e601 analyzer on (b)(6) 2016, resulting as 0. 462 coi (non-reactive). The second sample, from a (b)(6) female, initially resulted as 0. 564 coi (non-reactive) on the e601 analyzer on (b)(6) 2016. The sample was repeated at a different laboratory on an abbott architect analyzer on (b)(6) 2016, resulting as 1. 10 ratio (positive). The patients were not adversely affected. The e601 analyzer serial number was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[54905243]
A specific root cause could not be determined based on the provided information. Samples from the first patient were provided for investigation. A sample from the second patient was not available for investigation. Investigation of the first patient sample was able to confirm the customer's results. The sample showed (b)(6), but was still (b)(6) the cut-off for the elecsys cmv igm assay. The sample was (b)(6) when tested with the recomline cmv igm assay. The (b)(6) of the detected antibodies suggest that the first patient may have encountered a primary infection with (b)(6) 18-20 weeks prior to the sampling on (b)(6) 2016. The previous sample from this patient measured on (b)(6) 2015 did not show (b)(6) in the performed assays, indicating that the time point of infection must have been in close proximity to the first sampling date. Apparently, at this earlier time point significant antibody titers had not formed yet. Moreover, the later sample shows an only (b)(6) igm titer suggesting that this patient developed a (b)(6) response only, which renders early detection challenging. Alternatively, the maturation of igg antibodies might occur faster than average in this particular patient and the time point of primary infection was between the two samplings. No medical device problem was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00665 |
| MDR Report Key | 5669559 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-20 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-05-10 |
| Date Added to Maude | 2016-05-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2016-05-20 |
| Model Number | NA |
| Catalog Number | 04784618190 |
| Lot Number | 187017 |
| 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 | 2016-05-20 |