MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-04-05 for ARCHITECT INSULIN 08K41-26 manufactured by Abbott Laboratories.
[16431018]
Accuracy testing was performed with an in-house retained reagent kit of architect insulin assay list 08k41-26, lot 25020lp46. Four members of an insulin panel were tested in replicates of five on one isystems analyzer. All results met specifications, indicating that assay performance has not been compromised. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The architect insulin assay package insert contains information to address the current customer issue. The customer issue was isolated to a single patient sample. No further troubleshooting or information from the customer site was provided. Based on the information received from the customer site and the results of the current evaluation, it can be concluded that the architect insulin assay is performing as expected with no product issues found. A product malfunction was not identified.
Patient Sequence No: 1, Text Type: N, H10
[20632159]
The customer reports falsely elevated architect insulin assay results for one patient. An initial result of 291. 9 uu/ml was generated (current sample, date unknown). However, this sample was also tested with the auto-dilution mode of the analyzer (1:2 dilution) and a final result of 562. 3 uu/ml was generated. The sample was retested with an undiluted result of 299. 6 uu/ml and an auto-dilution result of 543. 4 uu/ml. The customer believes that the auto-dilution result is correct because a previous sample taken (on or about 29 march 2013) from this patient had generated a result of 590. 9 uu/ml. The customer then performed manual dilutions of the sample with the following results: current sample = 567. 7 uu/ml (1:2) and 843. 2 uu/ml (1:5); 29 march 2013 sample = 906. 9 uu/ml (1:5) and 1009. 6 uu/ml (1:10). The patient's insulin antibody test generated a result of greater than 50 u/ml. There is no report of any impact to patient care due to this issue.
Patient Sequence No: 1, Text Type: D, B5
[20899107]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00168 |
| MDR Report Key | 3037731 |
| Report Source | 01,05 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-03-29 |
| Date Mfgr Received | 2013-06-19 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-04-05 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT INSULIN |
| Product Code | CFP |
| Date Received | 2013-04-05 |
| Catalog Number | 08K41-26 |
| Lot Number | 25020LP46 |
| Device Expiration Date | 2013-11-11 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-04-05 |