MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-01 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[4431282]
The customer received questionable results for ion selective electrode (ise) potassium (k) on "a few" samples. It was determined that one sample had an erroneous result which was reported outside of the laboratory. The customer indicated they had been receiving ise reagent probe alarms. The customer indicated the probe did not appear bent or damaged, but that the probe was stuck on the side of one of the reagent bottles. The initial k result was 5. 3 mmol/l, which was reported outside of the laboratory. The sample was repeated on another cobas 6000 c501 instrument and generated a result of 3. 2 mmol/l. The customer deemed the repeat result to be correct and corrected the result. There was no adverse event. The lot number and expiration date of the k electrode in use was requested, but the customer could not provide this information. The field service representative found that the sampling assembly ise probe was misadjusted. He adjusted the sampling assembly ise probe and performed mechanical checks, which passed. He also performed precision testing, which passed. The customer indicated that qc met laboratory specifications. The investigation determined the mis-adjusted sampling assembly ise probe did not explain the fact that only erroneous k results were generated. The investigation could not determine a specific root cause with the information provided.
Patient Sequence No: 1, Text Type: D, B5
[11776824]
It was unknown if the initial reporter sent report to the fda. Results - device subassembly- ise sampling assembly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-03125 |
| MDR Report Key | 3783838 |
| Report Source | 05,06 |
| Date Received | 2014-05-01 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-04-16 |
| Date Mfgr Received | 2014-04-16 |
| Date Added to Maude | 2014-05-01 |
| 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 | 2014-05-01 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-01 |