MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE WHOLE BLOOD PRECIPITATION REAGENT KIT

Model Number	1L75-55
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased architect cyclosporine result which questioned by physician on one patient.The results provided were: initial=63 ng/ml /repeated=69 ng/ml /redrawn and repeated on same patient=170 ng/ml and 180 ng/ml /initial specimen repeated=69 ng/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
The initial report was submitted under manufacturer report number 3008344661-2022-00066-01 abbott (b)(4) as manufacturing site)with suspect medical device of architect cyclosporine reagent kit, list 3r30.After further evaluation, the suspect medical device was changed to architect cyclosporine whole blood precipitation reagent kit, list 1l75 abbott (b)(4) as manufacturing site , which is under this report.
Additional Manufacturer Narrative
This follow-up submission being send to cross reference mdr 1415939-2022-00060-00 for likely cause changed on 21jul2022; to architect cyclosporine reagent kit, list number 01l75-25, lot number 37701fp00 from architect cyclosporine whole blood precipitation reagent kit, list 01l75-55, lot number 310275.After further evaluation it was determined that the cause of the issue was the architect cyclosporine reagent kit, list 01l75-25, lot number 37701fp00.) (abbottpark, il as manufacturing site) and submitted under manufacturer report number 1415939-2022-00060-00.

• Brand Name: ARCHITECT CYCLOSPORINE WHOLE BLOOD PRECIPITATION REAGENT KIT
• Common Device Name: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14831877
• Report Number: 1415939-2022-00047
• Device Sequence Number: 4639892
• Product Code: MKW
• UDI-Device Identifier: 00380740001322
• UDI-Public: 00380740001322
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/04/2022

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 Model Number: 1L75-55
• Device Catalogue Number: 01L75-55
• Device Lot Number: 310275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown