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 2019-05-15 for COBAS B 101 HBA1C TEST 08038694190 manufactured by Roche Diagnostics.
[145101267]
This event occurred in (b)(6). Ten blood samples were tested with retention material b101 hba1c test disc lot 834042-01 on a b 101 instrument vs. The tosoh g8 internal reference method. Retention material results showed no issues. All results fulfill the specification. Retention material using retention cobas b101 instrument showed no hba1c deviation from tosoh g8. Device evaluated by mfr: the customer has no remaining discs to return.
Patient Sequence No: 1, Text Type: N, H10
[145101268]
The initial reporter complained of discrepant results for 1 patient tested for cobas hba1c test on a cobas b 101 instrument compared to an outsourced laboratory using the enzymatic analysis method. The result from the b 101 was 7. 3%. This result was reported outside of the laboratory where it was questioned by the doctor and the patient. The patient had changed their diet last month and was shocked to see a higher result than the last time they were tested for hba1c. The sample was sent to an external laboratory where the result was 6. 5%. The customer then retested the sample on a reagent disc with the same lot number that had been stored at room temperature and a reagent disc with the same lot number that had been refrigerated and the results were 6. 8% and 7. 1% respectively. The doctor mentioned that hba1c results have been higher for the past 2-3 days using this particular reagent lot. There was no allegation that an adverse event occurred. The b 101 instrument serial number was not provided. The reagent discs were requested for investigation, however, the reagent discs are no longer available to return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01816 |
| MDR Report Key | 8611227 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-15 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-15 |
| 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 | 3 |
| Brand Name | COBAS B 101 HBA1C TEST |
| Generic Name | ASSAY, GLYCOSYLATED HEMOGLOBIN |
| Product Code | LCP |
| Date Received | 2019-05-15 |
| Model Number | B 101 HBA1C |
| Catalog Number | 08038694190 |
| Lot Number | 834042-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-15 |