MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-09-04 for COBAS INTEGRA (800) HBA1C DEDICATED 04559126001 manufactured by Roche Diagnostics.
[12571015]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Review of the instrument alarm data, qc data and calibration data, did not indicate any issue. Coldness of the reagent is known to cause high results and it is recommended to perform a new calibration. As the customer did not perform qc or calibrations for each reagent cassette, this could not be ruled out as a possible cause.
Patient Sequence No: 1, Text Type: N, H10
[19768289]
The customer discovered questionable hemoglobin a1c results for 120 patient samples after the results for two patients were questioned by physicians. Of the data provided, the results for 94 patient samples were discrepant. On (b)(6) 2014, the pathologist received a call from a physician regarding a patient result of 8. 1%. He had the patient go back to the lab for another hemoglobin a1c test on (b)(6) 2014 and the result was 5. 4%. Both samples from the patient were retested and the result from the (b)(6) 2014 sample was 5. 4% and the result from the (b)(6) 2014 sample was 5. 6%. On (b)(6) 2014, the pathologist received another call from the same physician regarding a patient result of 8. 4%. The sample was repeated on (b)(6) 2014 and the result was 6. 2%. All patient samples that had been initially tested on (b)(6) 2014 were then repeated. Refer to the attachment to the medwatch for data from the additional 92 patients. All of the erroneous results were reported outside the laboratory. There was no adverse event. The hemoglobin a1c reagent lot number was 69127401. The expiration date was provided as 2015-02.
Patient Sequence No: 1, Text Type: D, B5
[19859979]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-06788 |
| MDR Report Key | 4059908 |
| Report Source | 01,05,06 |
| Date Received | 2014-09-04 |
| Date of Report | 2014-11-25 |
| Date of Event | 2014-08-17 |
| Date Mfgr Received | 2014-08-22 |
| Date Added to Maude | 2014-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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) HBA1C DEDICATED |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | PDJ |
| Date Received | 2014-09-04 |
| Model Number | NA |
| Catalog Number | 04559126001 |
| 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 | 2014-09-04 |