MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-06-09 for COBAS 6000 CORE UNIT 04745868001 manufactured by Roche Diagnostics.
[77407617]
(b)(4). This event occurred in (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[77407618]
The customer received a questionable gentamicin result for one patient sample. The customer also stated they are seeing imprecision and calibration failures with other assays, but no data was provided. The initial result prior to the patient receiving the dose was 5. 25 ug/ml and was reported to the doctor. The sample was repeated and the results were 0. 69 ug/ml and 0. 62 ug/ml. There was no allegation of an adverse event. The reagent lot number and expiration date were requested but were not provided. Calibration and qc results were all acceptable prior to the event. The customer stated the analyzer is currently contaminated by the water system. The field service representative was in the process of performing decontamination.
Patient Sequence No: 1, Text Type: D, B5
[83751083]
Additional information was provided that the unit of measure was mg/ml.
Patient Sequence No: 1, Text Type: N, H10
[117969269]
There have been no new occurrences since the water system and instrument were decontaminated. Technical issues with the device were excluded and the device is running within specification. No roche medical device issues were identified. The reagent involved in the event is manufactured by another device manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01186 |
| MDR Report Key | 6629198 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-09 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-06-09 |
| 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 6000 CORE UNIT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LCD |
| Date Received | 2017-06-09 |
| Model Number | COBAS 6000 CORE |
| Catalog Number | 04745868001 |
| 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 6000 CORE UNIT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-09 |
| Model Number | COBAS 6000 CORE |
| Catalog Number | 04745868001 |
| 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 | 2017-06-09 |