MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-02-16 for ARCHITECT INSULIN 8K41-26 manufactured by Abbott Laboratories.
[1935495]
The customer stated an abnormally high insulin value of 6831. 6 uu/ml was generated on the architect i2000 analyzer. The sample was retested and yielded a result of 11. 4 uu/ml. Based on testing the sample both neat and diluted, it was determined the correct insulin value was approximately 12 uu/ml and this value was reported. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8955697]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete. An investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
[9027200]
(b)(4). Refer to results of investigation below. To investigate the customer's issue, customer complaints received from (b)(6) 2010 through (b)(6) 2011 were reviewed to determine if others have experienced the same issue. Our review of this data did not identify any problems. Specifically, we did not see an increase in the number of complaints related to elevated discrepant patient results. Additional testing was performed on lot number 95020lp30 to ensure that the lot was performing acceptably. Serum based panels spiked with known concentrations of insulin were tested. The mean value for each of the panels (1-4) was within the specifications. The lot meets acceptance criteria. All testing materials were stored and maintained at abbott. Based on our investigation, we have concluded that the architect insulin assay is performing as intended and is meeting its safety, effectiveness, and label claims. A specific reason for the customer's observation could not be determined based on this investigation. The customer was referred to the "limitations of the procedure" section of the architect insulin assay package insert for further information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00034 |
| MDR Report Key | 1994058 |
| Report Source | 01 |
| Date Received | 2011-02-16 |
| Date of Report | 2011-01-28 |
| Date of Event | 2011-01-28 |
| Date Mfgr Received | 2011-04-15 |
| Device Manufacturer Date | 2010-11-02 |
| Date Added to Maude | 2012-01-27 |
| 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 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 | 8479375120 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3537 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT INSULIN |
| Generic Name | FOR THE DETERMINATION OF HUMAN INSULIN IN SERUM OR PLASMA |
| Product Code | CFP |
| Date Received | 2011-02-16 |
| Catalog Number | 8K41-26 |
| Lot Number | 95020LP30 |
| Device Expiration Date | 2011-08-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064353 US 60064 3537 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-16 |