FDA Adverse Event
Malfunction
Summary report: N
ARCHITECT C-PEPTIDE REAGENT
MDR report key: 2193631
·
Received August 5, 2011
Report
- Report Number
- 1415939-2011-00530
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- June 5, 2011
- Report Date
- June 17, 2011
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- JKD
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- 1415939-7/11/11-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(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.
Description of Event or Problem · 1
THE CUSTOMER OBSERVED ELEVATED (B)(4) PROFICIENCY SAMPLE RESULT WHEN ARCHITECT C-PEPTIDE REAGENT LOT 017110A000 WAS IN USE. THE ABBOTT QUALITY CONTROLS WERE WITHIN SPECIFICATIONS, THEREFORE, THE CUSTOMER RECALIBRATED THE ASSAY AND ABBOTT CONTROLS WERE WITHIN SPECIFICATION, HOWEVER, THE EQA RESULTS REMAINED ELEVATED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT C-PEPTIDE REAGENT | JKD | ABBOTT LABORATORIES | 01711A000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) SAMPLES| ARCHITECT I1000SR ANALYZER, LIST# 1L86-01 |