MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-17 for C.F.A.S. HBA1C 04528417190 manufactured by Roche Diagnostics.
[120712921]
Patient Sequence No: 1, Text Type: N, H10
[120712922]
The customer stated that they received questionable results for an unspecified number of patient samples tested for a1c-3 tina-quant hemoglobin a1c gen. 3 on a cobas 6000 c (501) module. The customer provided data for one patient sample which had an erroneous a1c-3 result that was reported outside of the laboratory. The complained sample was tested each time using a calibration from a different c. F. A. S. Hba1c calibrator lot number. This medwatch will apply to calibrator lot number 16006601. Please refer to the medwatch with patient identifier (b)(6) for information related to calibrator lot number 12635800. The complained patient sample initially resulted with an a1c-3 value of 11. 7 % on (b)(6) 2018 when using a calibration performed with calibrator lot 12635800. This initial value was reported outside of the laboratory. The customer started using calibrator lot number 16006601 on (b)(6) 2018. The first calibration performed with this new lot failed. The customer re-calibrated and then controls were outside of range. The customer calibrated a third time and controls were still outside of range. These controls were manufactured by mas and recovery shifted downward with the new calibrator lot. Roche controls were tested and these were within range and right on the mean. The customer verified that the calibrator set points were correct for the new calibrator lot. The customer pulled patient samples that were tested using a calibration from the older calibrator lot and repeated these using a calibration performed with the new calibrator lot. The samples that were pulled included the complained patient sample. When tested using the new calibrator lot, the complained sample resulted with an a1c-3 value of 10 % on (b)(6) 2018. The customer did not know which value from the complained sample was correct since roche controls were within range prior to each run of the sample. The patient was not adversely affected. The a1c-3 reagent lot number was 317513, with an expiration date of 30-sep-2019. The serial number of the c501 analyzer is (b)(4). The field service engineer stated that the issue was related to the new calibrator lot 16006601. He repeated calibration, mas controls, roche controls, and ran precision studies. Roche controls were within range, on the mean. The mas controls were within range and within one standard deviation of the mean. Precision studies were within specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03161 |
| MDR Report Key | 7881186 |
| Date Received | 2018-09-17 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-09-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | C.F.A.S. HBA1C |
| Generic Name | CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT |
| Product Code | KRZ |
| Date Received | 2018-09-17 |
| Model Number | NA |
| Catalog Number | 04528417190 |
| Lot Number | 16006601 |
| Device Expiration Date | 2019-01-31 |
| 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 | 2018-09-17 |