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 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party?: no.Complete information for patient information, patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated calcium results on alinity c processing module for two patients when replaced new lot of calcium reagent.The results were provided from previous lot of reagent lower than new lot of reagent.On (b)(6) 2021 sid (b)(6) =2.31 mmol/l /repeated with new lot of reagent=3.79 mmol/l sid (b)(6) =2.41 mmol/l /repeated=>6 mmol/l /dilution=4.39 mmol/l reference range for calcium=2.10 to 2.55 mmol/l there was no reported impact to patient management.

Manufacturer Narrative

Component code: g01003.A review of complaints determined that there are no trends for the product for the complaint issue.However, alinity calcium lot number 08429un20 review determined complaint activity was increased for this complaint issue.Return testing was not completed as returns were not available.File sample analysis was not performed as initial testing of the samples gave expected normal results with a previous reagent.There are lot to lot variation or differences between each reagent lot produced.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 calcium assay for lot 08429un20 was identified.

Manufacturer Narrative

This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• 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: 11641656
• MDR Text Key: 268516244
• Report Number: 3002809144-2021-00242
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2021

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: 03/09/2022
• Device Model Number: 07P5720
• Device Catalogue Number: 07P57-20
• Device Lot Number: 08429UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 04/14/2021; 06/21/2021
• Supplement Dates FDA Received: 04/15/2021; 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01141; ALNTY C PROCESSING MODU, 03R67-01, AC01141; ALNTY C PROCESSING MODU, 03R67-01, AC01141