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

Model Number 1L75-55

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 301026977
• Report Number: 1415939-2022-00047
• Device Sequence Number: 1
• Product Code: MKW
• UDI-Device Identifier: 00380740001322
• UDI-Public: 00380740001322
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/19/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)