MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-12 for COBAS 6000 C501 (UL) V 05860636001 manufactured by Roche Diagnostics.
[3935940]
The customer alleged they received questionable ion selective electrode (ise) potassium and sodium results for one patient on their c501 analyzer. The customer provided data for one discrepant potassium result that was reported outside the laboratory. The patient's sample was processed through the customer's modular pre analytics device. The patient's initial potassium result was 7. 1 mmol/l. The customer stated she called the doctor with this "critical" potassium result. The customer repeated the entire sample and the potassium result was 3. 8 mmol/l. The other assays repeated well with the initial results with the exception of the initial, questionable sodium result, which was not reported outside the laboratory. The patient was not adversely affected by this event. The potassium electrode lot number and expiration date were requested but not provided. The field service representative could not find a cause and could not duplicate the issue. He performed ise checks and a precision run. The ise checks performed without any errors and the precision results were within specification. The instrument was operating within specification.
Patient Sequence No: 1, Text Type: D, B5
[11258272]
A root cause could not be determined with the information provided. Additional details were requested but not provided.
Patient Sequence No: 1, Text Type: N, H10
[11273767]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-06822 |
| MDR Report Key | 3461983 |
| Report Source | 05,06 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-11-20 |
| Date of Event | 2013-10-28 |
| Date Mfgr Received | 2013-10-28 |
| Date Added to Maude | 2013-11-12 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 (UL) V |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NGS |
| Date Received | 2013-11-12 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| 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 | 2013-11-12 |