MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-10 for COBAS 6000 C501MODULE 05860636001 manufactured by Roche Diagnostics.
[3697067]
The customer received questionable results for ion selective electrode (ise) sodium (na) on one patient sample. All results are in mmol/l. The customer noticed that the ise diluent bottle did not switch over when it was empty, and an erroneous result was generated. The customer also noticed at the same time that the software indicated there were 150 tests remaining in the ise reference electrolyte (kcl) when the bottle was almost empty. The customer replaced the diluent and kcl and primed and it was back to normal. The original na result was 154, which was reported outside of the laboratory. The sample was repeated on another cobas 6000 c501 module and generated a repeat result of 136. The customer deemed the repeat result to be the correct result. There was no adverse event. The lot number of the na electrode was not provided by the customer. The field service representative found that the ise probe liquid level detection did not properly detect the low ise reagent volume status. He replaced the ise probe and the liquid level detection pcb. He retaught ise probe coordinates. The customer calibrated as needed. All controls were acceptable to the customer and the system was performing to specifications.
Patient Sequence No: 1, Text Type: D, B5
[10966198]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-04177 |
| MDR Report Key | 3216421 |
| Report Source | 05,06 |
| Date Received | 2013-07-10 |
| Date of Report | 2013-07-10 |
| Date of Event | 2013-06-24 |
| Date Mfgr Received | 2013-06-25 |
| Date Added to Maude | 2013-07-10 |
| 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 C501MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NGS |
| Date Received | 2013-07-10 |
| 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 | 2013-07-10 |