MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-05 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[10447589]
The investigation was not able to determine a specific root cause. Follow up with the customer confirmed that changing the sample probe resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
[19387963]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[19416574]
The customer received discrepant results for creatine kinase (ck) on one patient sample. All results are in u/l. The original result was 2212, accompanied by a data flag. The sample was re-run with the decreased sample volume option and generated a result of 782. This result was reported outside of the laboratory. It was noticed that the rerun result did not match with the original result; so an aliquot from the same sample was re-run. The re-run result was 2251, accompanied by a data flag. The sample was re-run with decreased sample volume option and generated a result of 2375. The result of 2375 was deemed to be the correct result by the customer. The customer checked with the physician and the patient was not adversely affected. The ck lot in use was 66688201, with an expiration date of 07/31/2013. The field service representative found that there was a fluidics failure of the sample probe. The sample probe tip was not dispensing properly. He replaced the sample probe. The customer performed qc, which was within their specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2012-06117 |
| MDR Report Key | 2858517 |
| Report Source | 05,06 |
| Date Received | 2012-12-05 |
| Date of Report | 2013-01-30 |
| Date of Event | 2012-11-28 |
| Date Mfgr Received | 2012-11-29 |
| Date Added to Maude | 2012-12-05 |
| 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 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2012-12-05 |
| 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 | 2012-12-05 |