MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-27 for COBAS 8000 C502 MODULE 05964067001 manufactured by Roche Diagnostics.
[3742305]
The customer received questionable results for qms gentamicin application (gent) on two patient samples. Of the two samples, it was determined that one sample had erroneous results that were reported outside of the laboratory. The patient had an initial gent result of 1. 88 ug/ml, which was reported outside of the laboratory. The customer repeated and generated a repeat result of 3. 85 ug/ml. The sample was repeated again and generated a result of 0. 64 ug/ml. The customer deemed the repeat result of 0. 64 ug/ml to be the correct result. The customer also indicated that they repeated the sample a fourth time on another instrument , which matched the repeat result of 0. 64 ug/ml. The customer confirmed that the patient was not harmed and there was no adverse event. The lot of gent reagent in use was 60144673, with an expiration date of 01/14/2014. The field service representative (fsr) was unable to determine a cause. The fsr indicated the customer moved the test to another instrument and was monitoring the results. On further follow up, the customer indicated they have not experienced the issue since moving the test to another instrument.
Patient Sequence No: 1, Text Type: D, B5
[11191575]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11260385]
The customer indicated they began to see the issue occur on the analyzer the assay was moved to. The new analyzer had a similar test menu as the original instrument. The customer stated they believe there was an interference between the gent assay and a third party acetaminophen assay. The customer added a special wash between the two assays. On further follow up, the customer has not observed the issue since adding the special wash. The gent reagent is manufactured by thermofisher. Thermofisher was notified of the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-05955 |
| MDR Report Key | 3372824 |
| Report Source | 05,06 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-11-21 |
| Date of Event | 2013-08-26 |
| Date Mfgr Received | 2013-09-03 |
| Date Added to Maude | 2013-09-27 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 8000 C502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LCD |
| Date Received | 2013-09-27 |
| Model Number | NA |
| Catalog Number | 05964067001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2013-09-27 |