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 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false elevated alinity c calcium result for a patient when running on the alinity c processing module.The following data was provided (customer¿s normal range: 8.5 ¿ 10.5 mg/dl): on (b)(6) 2021 = initial calcium result = 16.2 mg/dl, repeated on another alinity analyzer = 9.8, 9.5 mg/dl.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false elevated alinity c calcium results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search by lot 81839un21 did not identify an increase in complaint activity for the current issue.Trending was reviewed and did not identify any trends for the product for the issue.The device history record was reviewed, and no non-conformances or deviations were identified.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity c calcium, reagent lot 81839un21 was identified.

• 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: 12436326
• MDR Text Key: 277980258
• Report Number: 3002809144-2021-00560
• 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: 10/20/2021

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: 05/08/2022
• Device Model Number: 07P5720
• Device Catalogue Number: 07P57-20
• Device Lot Number: 81839UN21
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)