MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT INSULIN

Catalog Number 08K41-26

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

The customer stated that the architect analyzer generated falsely elevated insulin results on one patient sample.Sid (b)(6) initial insulin on (b)(6) 2014 = >300uu/ml / 1:2 dilution result = >600uu/ml.The patient sample was sent out and the lumipulse result = 2.0uu/ml.There was no additional patient information provided.There was no reported impact to patient management.

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, a review for similar complaints, accuracy testing, and a review of labeling.The customer reported falsely elevated insulin results.A review of complaints did not identify any issues for falsely elevated insulin results for lot 33020lp52.Accuracy testing was completed using retained kits of reagent lot 33020lp52.A deficiency was not identified as the testing showed that lot 33020lp52 performed per specification.The testing showed that acceptance criteria were met, which indicates the product is performing acceptably.No malfunction was identified.A review of labeling determined that the assay values were obtained with different methods, which cannot be used interchangeably, due to differences in assay methods and reagent specificity.No additional issues were identified; no further action is required at this time.Based on the investigation results there is no indication of a product deficiency and the architect insulin reagent is performing as intended.

• Brand Name: ARCHITECT INSULIN
• Type of Device: INSULIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3708272
• MDR Text Key: 4245117
• Report Number: 1415939-2014-00077
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/16/2014
• Device Catalogue Number: 08K41-26
• Device Lot Number: 33020LP52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT I2000 ANALYZER, LIST # 08C889-01,; ARCHITECT I2000 ANALYZER, LIST # 08C889-01,