MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-19 for D-100 HBA1C, D-100? HBA1C CALIBRATOR PACK 290-1004 manufactured by Bio-rad Laboratories, Inc..
[75599776]
Upon investigation the likely cause of the issue is attributed to an lis programming, a non-bio-rad product. There was no evidence of malfunction on the d-100 system and the system was performing per the manufacturer's specification at the time of incident. The customer discovered that the a1c result recorded in the d-100? System database, for this sample, was 5. 5 % (correct), not 11. 2%. The customer also evaluated the astm files and found that the result sent to the lis was also 5. 5%, not 11. 2%. Ifcc and eag values were also sent, but only the ngsp changed erroneously at the lis system. The customer uses one lis program for three different systems (two variant? Ii turbo systems (plus one pc) and one d-100? System). Although the lis vendor was not able to locate the raw data for this one sample, it was noted that the customer had corrected an unknown sample id (i. E. An unread barcode) sent by the variant? Ii turbo system at the lis. A sample result with an unknown sample id (i. E. Unread barcode) can overwrite a correctly-read barcode sample id if it had been transferred to lis at the same time. The customer was suggest to make edits of unread barcodes on the bio-rad system and not at the lis to avoid overwriting. The customer was also suggested to separate the lis pc from the d-100? System and variant? Ii turbo pc. Additional patient information was not provided by the customer due patient confidentiality. No further incident information has been provided by the customer. Bio-rad continues to track and trend any incident related to this issue. (may 4, 2017)
Patient Sequence No: 1, Text Type: N, H10
[75599777]
The physician treated the patient based on the incorrect result, 11. 2% hba1c that appears to caused patient harm. The d-100 hemoglobin testing system database review shows that the system correctly transmitted a 5. 5% hba1c, ngsp value to lis. The change to the patient's hba1c value occured outside of the custody of the d-100 hemoglobin testing system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2915274-2017-00010 |
| MDR Report Key | 6579958 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-19 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-03-20 |
| Date Added to Maude | 2017-05-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SWETA PATEL |
| Manufacturer Street | 4000 ALFRED NOBEL DRIVE |
| Manufacturer City | HERCULES CA 94547 |
| Manufacturer Country | US |
| Manufacturer Postal | 94547 |
| Manufacturer Phone | 5107415157 |
| Manufacturer G1 | BIO-RAD LABORATORIES, INC |
| Manufacturer Street | 4000 ALFRED NOBEL DRIVE |
| Manufacturer City | HERCULES CA 94547 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94547 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-100 HBA1C, D-100? HBA1C CALIBRATOR PACK |
| Generic Name | GLYCOSYLATED HEMOGLOBIN ASSAY |
| Product Code | PDJ |
| Date Received | 2017-05-19 |
| Model Number | 290-1004 |
| Catalog Number | 290-1004 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC. |
| Manufacturer Address | 4000 ALFRED NOBEL DRIVE HERCULES CA 94547 US 94547 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-19 |