MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT INSULIN

Catalog Number	08K41-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that an initial architect insulin result of 399.7 pmol/l was generated on a (b)(6) patient sample.The sample was not repeated at the time.The patient questioned the result as she had her blood drawn at another hospital on a different day and the results were 20 pmol/l.The method was unknown.The original sample had been disposed and is not available.There was no report of impact to patient management.
Additional Manufacturer Narrative
Customer complaint data was reviewed and no adverse trends were identified.A review for potential non-conformances, deviations or non-conformances was performed on architect insulin lot 82121lp01 and none were identified.Accuracy testing was also performed to evaluate the performance of reagent lot 82121lp01.An internal insulin panel was tested with retained kits of the likely cause reagent lot.Acceptance criteria were met, which indicates acceptable product performance.The architect insulin reagent package insert was reviewed and was found to adequately address the issue.Use error may have contributed to the customer's issue as the customer was comparing the architect results to results obtained on an unknown instrument type.Per product labeling, values obtained with different assay methods cannot be used interchangeably.Based on the available information no product deficiency of the architect insulin assay was identified.

• Brand Name: ARCHITECT INSULIN
• Common Device Name: INSULIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7485180
• Report Number: 1415939-2018-00085
• Device Sequence Number: 11148722
• Product Code: CFP
• UDI-Device Identifier: 00380740017569
• UDI-Public: 00380740017569
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2018
• Device Catalogue Number: 08K41-27
• Device Lot Number: 82121LP01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR