MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-07-06 for COBAS 8000 C502 MODULE 05964067001 manufactured by Roche Diagnostics.
[48938971]
Patient Sequence No: 1, Text Type: N, H10
[48938972]
The customer stated that they received an erroneous result for one patient sample tested for cedia gentamicin ii (gent) on a c502 analyzer. The patient was a premature infant. The sample initially resulted as 8. 0 ug/ml and this value was reported outside of the laboratory to the pharmacist. The pharmacist did not believe the result, so he requested a repeat of the sample. The sample was repeated, resulting as 1. 1 ug/ml. The repeat value of 1. 1 ug/ml was believed to be the correct result and it was reported outside of the laboratory. The patient was not adversely affected. The gent reagent lot number was 70695874, with an expiration date of 11/30/2016. The field service representative could not determine a root cause for the issue. He checked the analyzer fluidics and optics. He ran precision studies.
Patient Sequence No: 1, Text Type: D, B5
[50746052]
Investigations have determined that the used gent reagent is not labeled for use on the c502 analyzer. There was no indication of a problem with the analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00856 |
| MDR Report Key | 5772840 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-06 |
| Date of Report | 2016-07-18 |
| Date of Event | 2016-06-17 |
| Date Mfgr Received | 2016-06-21 |
| Date Added to Maude | 2016-07-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| 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 | 2016-07-06 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 8000 C502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-07-06 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-06 |