MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT INSULIN

Model Number 08K4128

Device Problem High Test Results (2457)

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

Event Date 03/06/2020

Event Type  malfunction  

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 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.

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
• Type of Device: INSULIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9881724
• MDR Text Key: 190828721
• Report Number: 3002809144-2020-00217
• Device Sequence Number: 1
• Product Code: CDP
• UDI-Device Identifier: 00380740169824
• UDI-Public: 00380740169824
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR PROCESSING MODULE; ARCHITECT I1000SR PROCESSING MODULE; LIST 01L86-40, SERIAL (B)(6); LIST 01L86-40, SERIAL (B)(6)
• Patient Age: 14 YR