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 2017-07-12 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[80078566]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80078567]
The customer experienced issues with high albt2 tina-quant albumin gen. 2 results for qc material and patient samples since (b)(6) 2017. The customer tried different lots of qc material, calibrated multiple times some of which failed with errors, and changed the sample probe and reaction cells. Data was provided for one patient tested on (b)(6) 2017. The initial albt2 result on a urine sample was 33 mg/l and the repeat result on (b)(6) 2017 was 25 mg/l. The erroneous result was reported outside the laboratory. The patient was not adversely affected. The reagent lot number was 219743. The expiration date was requested but was not provided. The field service representative found there was a misadjusted rinse volume on the sample probe wash station. He adjusted the rinse volume and the customer ran calibration, qc, and precision testing with results within specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01448 |
| MDR Report Key | 6705385 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-12 |
| Date of Report | 2017-07-12 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-06-27 |
| Date Added to Maude | 2017-07-12 |
| 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 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJW |
| Date Received | 2017-07-12 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-12 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-12 |