MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-05-24 for ARCHITECT INSULIN 08K41-26 manufactured by Abbott Laboratories.
[9831477]
The customer did not provide the lot number of the architect insulin assay reagent used at their site. Therefore, a historical review of accuracy testing was performed for this list number. All results were within specification, indicating the assay is capable of accurately detecting various levels of the insulin analyte. 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 (list 08k41) contains information to address the customer's current issue. Based on the results of the current investigation, the architect insulin assay is performing as designed. A product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
[21750839]
The customer observed an alleged falsely elevated architect insulin assay result on one patient. The patient is not diabetic and the customer did not provide any reason why the insulin level for this patient was being monitored. In the morning of (b)(6) 2012, the patient generated an architect insulin result of 13. 3 uu/ml (sample #1). The evening sample (#2) of that same date generated a result of 633 uu/ml (auto-dilution). The following morning, sample (#3) generated a result of 143 uu/ml. The customer is questioning the elevated result of 633 uu/ml; however, the patient's physician did not comment on any of the insulin results. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[21924970]
An investigation is in process. A follow-up report will be submitted when the investigation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2012-00217 |
| MDR Report Key | 2587376 |
| Report Source | 01 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-05-21 |
| Date Mfgr Received | 2012-06-04 |
| Date Added to Maude | 2012-09-28 |
| 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 | 2012-05-24 |
| Catalog Number | 08K41-26 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-05-24 |