MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ICARBAMAZEPINE

Catalog Number	01P36-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.Investigation of the customer issue included a review of the complaint text, review of validated instrument data analytics, batch record review, a search for similar complaints, and a review of labeling.Return material was not available.No upshift of the median value could be observed for the complaint lot.The batch record review did not identify any non-conformances or deviations.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information a product deficiency of the architect icarbamazepine reagent, list number 01p36, lot number 60736li00 was not identified.
Event or Problem Description
The customer observed falsely elevated carbamazepine results while using the architect carbamazepine assay.Therapeutic range 4.0 - 12.0ug/ml, >20.0ug/ml toxic.The customer provided the following results (ug/ml): sid (b)(6): (b)(6) 2016: initial > 15 (flagged result), retested (1:4 dilution) 50.40.Retested using new reagent pack: 10.61.No impact to patient management was reported.

• Brand Name: ARCHITECT ICARBAMAZEPINE
• Common Device Name: CARBAMAZEPINE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 6525467
• Report Number: 3002809144-2017-00047
• Device Sequence Number: 11173329
• Product Code: KLT
• UDI-Device Identifier: 00380740081072
• UDI-Public: 00380740081072
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K103627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2017

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: 12/17/2016
• Device Catalogue Number: 01P36-27
• Device Lot Number: 60736LI00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 04/27/2017
• 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 I2000SR ANALYZER; LN 03M74-02, SN (B)(4)