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 2016-04-13 for PROLACTIN G2 03203093190 manufactured by Roche Diagnostics.
[42532373]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[42532374]
The customer stated that they installed a new e601 analyzer in (b)(6) and immediately, the customer noticed that results measured for prolactin were always higher than the reference ranges. The customer sent two patient samples that were tested for prolactin on the e601 analyzer to a different laboratory for repeat testing on a siemens centaur analyzer. These two samples had erroneous prolactin results when tested on the e601 analyzer. It was asked, but it is unknown if any erroneous results were reported outside of the laboratory. The first sample initially resulted as 34. 01 ng/ml when tested on the e601 analyzer. The sample was repeated at the other laboratory on the siemens centaur analyzer, resulting as 24. 0 ng/ml. The second sample initially resulted as 42. 97 ng/ml when tested on the e601 analyzer on (b)(6) 2016. The sample was repeated at the other laboratory on the siemens centaur analyzer, resulting as 30. 4 ng/ml on (b)(6) 2016. The patients were not adversely affected. The e601 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[43729004]
The customer has stated that the samples were later measured with both the elecsys prolactin assay and the tosoh aia method. The tosoh aia method results were comparable to the elecsys results. The customer now believes that the elecsys prolactin results are correct. The investigation stated that the differences in methodology between the elecsys and centaur methods may lead to differences in results. There is no general reagent issue present.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00428 |
| MDR Report Key | 5573588 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-13 |
| Date of Report | 2016-04-25 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-24 |
| Date Added to Maude | 2016-04-13 |
| 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 | PROLACTIN G2 |
| Generic Name | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Product Code | CFT |
| Date Received | 2016-04-13 |
| Model Number | NA |
| Catalog Number | 03203093190 |
| Lot Number | 188354 |
| 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 | 2016-04-13 |