MAUDE Adverse Event Report: ABBOTT GMBH AMYLASE; CATALYTIC METHODS, AMYLASE

Model Number	7D58-22
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
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.Patient identifier: multiple = (b)(6).
Event or Problem Description
The customer identified an issue with the architect amylase reagent on the architect c16000.The customer obtained multiple (sample id (b)(6)) inaccurate glucose result that were flagged <0.28 mmol/l.When the analyzer was inspected they found amylase in the carousel position the analyzer indicated glucose was in therefore indicating the analyzer may have read the amylase reagent as glucose.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a search for similar complaints, trending data review, labeling review, device history record review, and investigation by the third party manufacturer of the retained reagent lot.Return testing was not completed as returns were not available.The third party manufacturer, sekisui, investigated the complaint by scanning 14 cartridges of glucose reagent lot 61585uq02 and 15 cartridges of amylase reagent lot 61453uq01 from several retained kits on an architect system.All labels scanned appropriately with no errors found.The ticket search by lot did not identify abnormal complaint activity for the current complaint issue.A review of tracking and trending did not identify any trends related to the complaint issue.Device history record review did not identify any non-conformances or deviations related to the complaint list number and issue.Review of product labeling was found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the amylase reagent kit, lot 61453uq01, was identified.

• Brand Name: AMYLASE
• Common Device Name: CATALYTIC METHODS, AMYLASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15451296
• Report Number: 3002809144-2022-00330
• Device Sequence Number: 2919199
• Product Code: JFJ
• UDI-Device Identifier: 00380740161668
• UDI-Public: 00380740161668
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 07/17/2024
• Device Model Number: 7D58-22
• Device Catalogue Number: 07D58-22
• Device Lot Number: 61453UQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC C16K PRC MOD, 03L77-01, (B)(6) ; ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Sex: Unknown