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 2018-07-05 for ELECSYS PROLACTIN ASSAY 03203093190 manufactured by Roche Diagnostics.
[113182115]
(b)(4). (b)(6)
Patient Sequence No: 1, Text Type: N, H10
[113182116]
The customer complained of questionable elecsys prolactin assay results for 1 patient sample tested on cobas 8000 e 602 module compared to a abbott i 2000. The initial prolactin cobas e602 result was 931. 1 uiu/ml. The abbott prolactin result was 690. 06 uiu/ml. Polyethylene glycol (peg) treatment was performed on the patient sample and the sample was retested on both the cobas e602 and the abbott i 2000 at a 2x dilution. The peg treated cobas e602 prolactin result was 756 uiu/ml. The peg treated abbott i 2000 result was 550. 6 uiu/ml. For a non pregnant female the cobas e602 reference range is 102 - 496 uiu/ml and the abbott reference range is 5. 18 - 26. 53 ng/ml (108. 8 - 557. 1 uiu/ml). The erroneous results were not released outside of the laboratory. There was no allegation of an adverse event. The cobas e602 serial number was (b)(4). The investigation is currently ongoing
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02195 |
| MDR Report Key | 7663394 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-05 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-07-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | ELECSYS PROLACTIN ASSAY |
| Generic Name | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Product Code | CFT |
| Date Received | 2018-07-05 |
| Model Number | NA |
| Catalog Number | 03203093190 |
| Lot Number | 24861500 |
| ID Number | NA |
| Device Expiration Date | 2018-10-31 |
| 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 | 2018-07-05 |