MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-27 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[4244989]
The customer received questionable low ion selective electrode (ise) potassium results for 25 patient samples. The samples were repeated on another cobas c501 analyzer. Of the data provided, only the results for 19 patient samples were discrepant. The initial questionable results were reported outside the laboratory. The repeat results were believed to be correct. There were no adverse events. The potassium electrode lot number and expiration date were requested, but were not provided. The field service representative found there was a possible clot in the ise probe or tubing. He performed corrective maintenance on the ise module and replaced the pinch tubing, sipper probe, sample probe and ise syringe seals as a precaution. He ran ise checks which passed. The customer ran calibration as needed. All controls were acceptable to customer and the system was performing to specifications.
Patient Sequence No: 1, Text Type: D, B5
[11582684]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11587028]
Based on the provided calibration data, the investigation determined there were issues with the standards and reagents. Most likely a handling issue occurred such as contaminated standard vessels or the diluent contaminated by kcl.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-02140 |
| MDR Report Key | 3704462 |
| Report Source | 05,06 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-03-28 |
| Date of Event | 2014-03-13 |
| Date Mfgr Received | 2014-03-14 |
| Date Added to Maude | 2014-03-27 |
| 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 | 0 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2014-03-27 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-27 |