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 2017-09-29 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[89489848]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[89489849]
The customer had issues with questionable elecsys testosterone ii assay results for proficiency material and patient samples. Data was provided for three patient samples. Patient 1 initial result was 8. 47 nmol/l and the repeat result was 2. 01 nmol/l. Patient 2 initial result was 6. 31 nmol/l and the repeat result was 0. 64 nmol/l. Patient 3 initial result was 5. 06 nmol/l and the repeat result was 0. 602 nmol/l. Only the erroneous initial result for patient 2 was reported outside the laboratory. Only the repeat results were reported for patients 1 and 3. There was no allegation of an adverse event. The reagent lot number and expiration date were requested but were not provided. Multiple service visits were performed and it was determined the extra wash station (ews) sipper lines and the reagent probe were blocked. These were cleaned. It was also found that the procell syringe was contaminated and had crystallization. This was drained, removed, and cleaned. Signs of liquid and dirt were found on the valve, which was cleaned. The measuring cells were changed and new tubing, nozzles, and probes were installed. Analyzer performance testing was completed and was acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02144 |
| MDR Report Key | 6903389 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-29 |
| Date of Report | 2018-06-27 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-06-06 |
| Date Added to Maude | 2017-09-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CDZ |
| Date Received | 2017-09-29 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-29 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| Lot Number | NA |
| 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 | 2017-09-29 |