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 2018-08-03 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 04784596190 manufactured by Roche Diagnostics.
[116092238]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[116092239]
The customer complained of false positive elecsys cmv igg assay results for 1 patient sample on the cobas 8000 e 801 module. The e 801 module serial number was asked for not provided. The initial cmv igg result was >500 u/ml. Using a different sample tube from the same blood collection, the cmv igg results were 492 u/ml, 490 u/ml, 487 u/ml, and 428 u/ml. The cmv igg result was < 4 ua/ml with the vidas biomerieux method. It was not clear which sample tube was used. On (b)(6) 2018 a new sample was collected and the cmv igg result was 500 u/ml with a data flag. The sample was repeated with a 1:20 dilution and the cmv igg result was 437 u/ml. The cmv igg reagent lot number was 252325 with an expiration date of 30-sep-2018. There was no allegation of an adverse event. The sample was provided for investigation and the result was non-reactive. The customer's cmv igg result was not confirmed. The provided qc data was acceptable. A general reagent issue was excluded. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02600 |
| MDR Report Key | 7748234 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-03 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-08-03 |
| 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 | CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2018-08-03 |
| Model Number | NA |
| Catalog Number | 04784596190 |
| Lot Number | 252325 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-08-03 |