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 2015-11-06 for COBAS 8000 C701 MODULE 05641489001 manufactured by Roche Diagnostics.
[30655517]
This event occured in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[30655518]
The customer received questionable calcium gen. 2 results for an unknown number of patient samples beginning on (b)(6) 2015. The customer provided data for approximately 3200 patient samples tested (b)(6) 2015. Of the data provided, only the results for four patient samples tested on (b)(6) 2015 were discrepant. Patient sample 1 initial result was 1. 49, the repeat result was 2. 24. Patient sample 2 initial result was 0. 65, the repeat result was 1. 56. Patient sample 3 initial result was 3. 04, the repeat result was 2. 03. Patient sample 4 initial result was 1. 21, the repeat result was 2. 43. The unit of measure was not provided. The erroneous results were reported outside of the laboratory. There was no adverse event reported. The reagent lot number was 616835. The expiration date was requested, but was not provided. It was noted the customer was not cleaning the water tanks appropriately. However, after thorough cleaning of the tanks, the issue remained.
Patient Sequence No: 1, Text Type: D, B5
[33669597]
The unit of measure was mmol/l.
Patient Sequence No: 1, Text Type: N, H10
[43880558]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on the provided calibration and qc data, a general reagent problem was possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04459 |
| MDR Report Key | 5208255 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-06 |
| Date of Report | 2016-04-20 |
| Date of Event | 2015-10-19 |
| Date Mfgr Received | 2015-10-19 |
| Date Added to Maude | 2015-11-06 |
| 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 C701 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CIA |
| Date Received | 2015-11-06 |
| Model Number | NA |
| Catalog Number | 05641489001 |
| 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 46250 US 46250 |
| Brand Name | COBAS 8000 C701 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-11-06 |
| Model Number | NA |
| Catalog Number | 05641489001 |
| 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 | 2015-11-06 |