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.
[2042139]
The customer observed a higher than expected architect c-peptide result for a diabetic patient which was inconsistent with the patient's insulin values. The customer stated the c-peptide quality controls were within 1sd, however, external controls were high. The customer performed a series of dilutions to rule out possible heterophilic antibody interference and the results obtained confirmed the initial elevated result. The customer called the patient to come back for a second blood draw (no data provided) however, the customer recalibrated the assay between the first and second blood draw with no change in the control values. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[9146739]
(b)(4). 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 | 1415939-2011-00522 |
| MDR Report Key | 2194243 |
| Report Source | 01,05 |
| Date Received | 2011-08-06 |
| Date of Report | 2011-07-06 |
| Date Mfgr Received | 2011-07-11 |
| Device Manufacturer Date | 2011-03-31 |
| 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 | 01711A000 |
| Device Expiration Date | 2011-12-12 |
| 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 |