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 2015-11-12 for COBAS INTEGRA 800 28122474692 manufactured by Roche Diagnostics.
[30993200]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30993201]
The customer discovered questionable hemoglobin a1c results had been released when the qc was found out of range. The customer repeated approximately (b)(4) patient samples on another analyzer. Of the data provided for (b)(4) patient samples, only the results for (b)(4) patient samples were discrepant. Refer to the attachment to the medwatch for all patient data. The repeat results were believed to be correct. The customer stated they issued corrected reports. The customer did not know if any patient was adversely affected. The reagent lot number was 608019. The expiration date was requested, but was not provided. The field service representative found a problem with the photometer optics. He performed diagnostics and verified the sample and reagent volume. He reviewed previous calibrations, performed a sensitivity check, and replaced the photometer optics and shutter motor. He replaced the lamp and performed an air/water calibration. The customer ran qc.
Patient Sequence No: 1, Text Type: D, B5
[33639361]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04523 |
| MDR Report Key | 5219966 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-11-12 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-10-27 |
| Date Mfgr Received | 2015-10-27 |
| Date Added to Maude | 2015-11-12 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LCD |
| Date Received | 2015-11-12 |
| Model Number | NA |
| Catalog Number | 28122474692 |
| 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 INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-11-12 |
| Model Number | NA |
| Catalog Number | 28122474692 |
| 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 | 2015-11-12 |