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 2018-12-17 for ELECSYS SHBG 07258496190 manufactured by Roche Diagnostics.
[131009250]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[131009251]
The customer complained of questionable elecsys shbg results for 4 patient samples on a cobas 8000 e 801 module serial number (b)(4) compared to the beckman method. Of the data provided, there were discrepant shbg results for 2 patient samples. For patient 1 the shbg result on the e801 was 134 nmol/l and the repeat result on with beckman was 92. 6 nmol/l. For patient 2 the shbg result on the e801 was 138 nmol/l and the repeat result on with beckman was 105. 9 nmol/l. The patient was an (b)(6) male. There was no allegation of an adverse event. No erroneous results were reported outside of the laboratory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04911 |
| MDR Report Key | 8168636 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-12-17 |
| 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 | ELECSYS SHBG |
| Generic Name | TESTOSTERONE TEST SYSTEM |
| Product Code | CDZ |
| Date Received | 2018-12-17 |
| Model Number | NA |
| Catalog Number | 07258496190 |
| Lot Number | ASKU |
| 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 | 2018-12-17 |