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 2017-11-16 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 07027117190 manufactured by Roche Diagnostics.
[93380084]
(b)(4). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93380085]
The customer complained of questionable results for 1 patient tested for elecsys cmv igg assay (cmv igg) and elecsys cmv igm immunoassay (cmv igm) on a cobas 8000 e 801 module with a serial number of (b)(4). Of the data provided only the false negative result for cmv igg is a reportable malfunction. On (b)(6) 2017 sample a had a cmv igg result from a cobas e801 of 1. 16 u/ml (positive). On (b)(6) 2017 a new sample was drawn, sample b, and the cmv igg initial and rerun results from a cobas e801 were 0. 324 u/ml (negative) and 0. 315 u/ml (negative). Sample b was tested on a vidas system in the same laboratory with a cmv igg result of 10 au/ml (positive). Sample b was also tested on a vidas system in another laboratory with a cmv igg result of 10 au/ml (positive). Also on the vidas system in another laboratory a cmv igg avidity result of 0. 30 (units not provided) was obtained. Sample b was tested on a liason xl-diasorin in another laboratory with a cmv igg result of 50. 8 au/ml (positive). It was unknown if the questionable results were reported outside of the laboratory. There was no allegation of an adverse event. The customer is unable to make a conclusive decision. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02631 |
| MDR Report Key | 7037714 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-16 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-10-13 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-11-16 |
| 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 | 2017-11-16 |
| Model Number | NA |
| Catalog Number | 07027117190 |
| Lot Number | 212200 |
| ID Number | NA |
| Device Expiration Date | 2018-04-30 |
| 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 | 2017-11-16 |