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 2017-03-23 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 04784596190 manufactured by Roche Diagnostics.
[70759257]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6). Phone was provided as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[70759258]
The customer received questionable elecsys (b)(6) assay results for one patient sample. The result from cobas 8000 e 602 module serial number (b)(4) was < 0. 15 u/ml ((b)(6)). The result in another laboratory also using a cobas 8000 e 602 module was < 0. 15 u/ml ((b)(6)). The serial number of this analyzer was requested, but could not be provided. At an external laboratory, the (b)(6) (abbott) result was 34. 1 au/ml (cut off < 6 au/ml). At another laboratory, the (b)(6) (enzygnost) eia result was 623 mpeiu/ml (cut off < 200 mpeiu/ml). The result from the cobas 8000 e 602 modules was reported outside the laboratory. The physician was confused about the different results. There was no allegation of an adverse event. The calibration results were within the expected ranges. The customer was using incorrect target values for the control material. Sample from the patient was submitted for investigation.
Patient Sequence No: 1, Text Type: D, B5
[75223719]
Testing of the provided patient sample reproduced the customer? S (b)(6) result. The elecsys (b)(6) result was > 0. 0 u/ml ((b)(6)) and elecsys (b)(6) result was > 0. 215 coi ((b)(6)). Further testing confirmed the elecsys (b)(6) results were all correct as (b)(6). The recomline blot for (b)(6) results were both (b)(6). There was no failure or problem with the reagent detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00623 |
| MDR Report Key | 6428120 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-23 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-02-16 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-03-23 |
| 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 | 2017-03-23 |
| 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 | 2017-03-23 |