MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-08-06 for ARCHITECT C-PEPTIDE REAGENT 03L53-25 manufactured by Abbott Laboratories.
[2042140]
The customer observed a falsely elevated architect c-peptide patient result when reagent lot 00110l000 was in use. The customer was performing a correlation between the lumipulse f method and the architect c-peptide assay and observed the discrepant result for a type 1 diabetic patient sample. Another sample from the same patient was tested and a repeat elevated result was generated even after centrifugation of the sample. The customer also tested aliquot samples from the same patient which were collected before and after a meal. The customer also observed poor dilution linearity with the suspect sample, therefore, the customer decided there was a high possibility of non specific reaction of the diabetic patient sample with the architect c-peptide assay. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[9146740]
(b)(4): high test results. The cause of the architect c-peptide falsely elevated quality controls and patient results was due to a new antibody lot used in the manufacturing of the c-peptide microparticle and/or conjugate reagents. Abbott issued a product recall letter to all customers with instructions to discard and destroy any remaining inventory of the affected lots.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00532 |
| MDR Report Key | 2194245 |
| Report Source | 01,05 |
| Date Received | 2011-08-06 |
| Date of Report | 2011-06-30 |
| Date Mfgr Received | 2011-07-11 |
| Device Manufacturer Date | 2011-01-10 |
| Date Added to Maude | 2012-05-21 |
| 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 | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-7/11/11-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT C-PEPTIDE REAGENT |
| Product Code | JKD |
| Date Received | 2011-08-06 |
| Catalog Number | 03L53-25 |
| Lot Number | 00110L000 |
| Device Expiration Date | 2011-10-29 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-06 |