MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-13 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[3136224]
The customer received questionable results on partner channel gentamicin (gentq) for two patient samples. All results are in ug/ml. Patient 1 had an estimated initial result of about 6. 2, which was reported outside of the laboratory. The nursing staff questioned the result. The repeat result was about 1. 2 and was considered to be the correct result. There was no adverse event. Patient 2, male, (b)(6), had an initial gentq result of 4. 59 on (b)(6) 2013, which was reported outside of the laboratory. The laboratory tech noticed that the sample had been ordered as a trough level and initiated a repeat. The nursing staff called at about the same time to question the result. The repeat result was generated on the same analyzer and was 1. 12. The customer believed the repeat result to be correct and a corrected report was issued. There was no adverse event. The lot of qms gentamicin reagent was 59701808, with an expiration date of 10/31/2013. The field service representative found that the sample probe internal wash was not at the required volume, which was caused by the gear pump pressure. He replaced the gear pump head. He did performance testing, which was within specification.
Patient Sequence No: 1, Text Type: D, B5
[10517895]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-00853 |
| MDR Report Key | 2958752 |
| Report Source | 05,06 |
| Date Received | 2013-02-13 |
| Date of Report | 2013-02-13 |
| Date of Event | 2013-01-19 |
| Date Mfgr Received | 2013-01-29 |
| Date Added to Maude | 2013-02-13 |
| 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 | LCD |
| Date Received | 2013-02-13 |
| 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 | 2013-02-13 |