MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT; AZO DYE, CALCIUM

Model Number 07P5720

Device Problem High Test Results (2457)

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

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

No additional patient information is available.(b)(4).Was this device serviced by a third party? no.A review of tickets was performed for reagent lot number 03169un20.The ticket search determined that there is normal complaint activity for the reagent 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.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 alinity c calcium reagent ln 7p57-20/lot number 03169un20 was identified.

Event Description

The customer generated falsely elevated alinity c calcium results for one patient.The customer uses the reference range 8.5-10.5 mg/dl.The following information was provided: sid:(b)(6), initial result 14.23 mg/dl, repeat 9.69 and 9.52 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: ALINITY C CALCIUM REAGENT KIT
• Type of Device: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11510207
• MDR Text Key: 267163801
• Report Number: 3002809144-2021-00176
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (y/n): N
• PMA/PMN Number: K062855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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: 12/21/2021
• Device Model Number: 07P5720
• Device Catalogue Number: 07P57-20
• Device Lot Number: 03169UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 06/20/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC02239; ALNTY C PROCESSING MODU, 03R67-01, AC02239