MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-02 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[89574161]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89574164]
The customer stated the qc results for elecsys testosterone ii assay had been running high. They tested a different lot of qc material and the results were still high. Precision testing with qc material was performed and failed. A patient correlation was then performed with previously tested patient samples. One example was provided. The initial result on (b)(6) 2017 was 190. 1 ng/dl and the repeat result on (b)(6) 2017 was 276. 3 ng/dl. They customer did not know which result was correct and stated questionable results may have been reported outside the laboratory for up to 20 patient samples. Information concerning if any patient was adversely affected was requested but it was unknown. The reagent lot number was 19105304 with an expiration date of 28-feb-2018. The field application specialist took some of the customer's reagents, calibrators, and qc material to another site for troubleshooting. The field service representative found the sipper nozzle needed to be replaced. He replaced the sipper nozzle and the tubing. He ran performance testing which passed. Further investigation found the issue with the sipper nozzle was the cause of the event. A query was performed and found no past or new issues of this nature on any like instruments for the last 12 months at this site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02164 |
| MDR Report Key | 6907272 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-02 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2017-10-02 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CDZ |
| Date Received | 2017-10-02 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-10-02 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-10-02 |