MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2011-07-17 for ARCHITECT C-PEPTIDE REAGENT 3L53-25 manufactured by Abbott Laboratories.
[2105483]
The architect c-peptide assay is a chemiluminescent microparticle assay for the quantitative determination of c-peptide in human serum, plasma and urine and is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. During a complaint investigation, a product deficiency was identified for architect c-peptide reagents, list # 3l53-25, lots 03610k000 and 01711a000, which have the potential to generate falsely elevated results with certain patient samples and non-abbott quality controls. Abbott controls do not exhibit this shift. A product recall was issued and reported under 21cfr806 for the architect c-peptide reagent to the (b)(4) district on (b)(4) 2011. Abbott has not received any reports of adverse events related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[9256711]
Suspect medical device, lot #: additional suspect lots: 01711a000, manufacture date: (b)(4) 2011, expiration date: 12/12/11, (b)(4), manufacture date: (b)(4) 2011, expiration date: 10/29/11, (b)(4), manufacture date: (b)(4) 11, expiration date: 1/10/12, (b)(4), manufacture date: (b)(4) 2011, expiration date: 4/16/12. Patient: no consequences or impact to patient (b)(4); (b)(4). Device: high test results (b)(4); (b)(4) the cause of the architect c-peptide falsely elevated quality control 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
[9405202]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00515 |
| MDR Report Key | 2165565 |
| Report Source | 00,07 |
| Date Received | 2011-07-17 |
| Date of Report | 2011-07-11 |
| Date of Event | 2011-07-11 |
| Date Mfgr Received | 2011-08-19 |
| Device Manufacturer Date | 2010-12-17 |
| Date Added to Maude | 2012-05-22 |
| 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 | 2011-07-17 |
| Catalog Number | 3L53-25 |
| Lot Number | 03610K000 |
| Device Expiration Date | 2011-10-26 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-07-17 |