MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT INSULIN

Model Number	08K4128
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information: patient information: patient identifier: sli04904700.Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated architect insulin result for a (b)(6) year old patient.The following data was provided: 06mar2020 sid sli04904700 initial result = 84.8 iu/ml, previous sample 04mar2020 result = 54.7 iu/ml, additional data provided for glucose = 113 without fasting with a history of 89 and 98 fasting.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets was performed for reagent lot number 10221lp39.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing was performed using an internal insulin panel which was tested with a retained kit of lot 10221lp39.Acceptance criteria were met, which indicates acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect insulin for lot 10221lp39 was identified.

• Brand Name: ARCHITECT INSULIN
• Common Device Name: INSULIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9881724
• Report Number: 3002809144-2020-00217
• Device Sequence Number: 14376757
• Product Code: CDP
• UDI-Device Identifier: 00380740169824
• UDI-Public: 00380740169824
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 08/08/2020
• Device Model Number: 08K4128
• Device Catalogue Number: 08K41-28
• Device Lot Number: 10221LP39
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR PROCESSING MODULE; ARCHITECT I1000SR PROCESSING MODULE; LIST 01L86-40, SERIAL (B)(6); LIST 01L86-40, SERIAL (B)(6)
• Patient Age: 14 YR