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 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier is (b)(6).No additional patient demographic information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer questioned alinity c calcium results for one patient.The following information was provided: on (b)(6) 2021, sid (b)(6), initial result: 5.8 mmol/l, repeated 2.3 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for alinity c calcium reagent list number (ln) 07p57-30, lot number 46997un21.A review of tickets was performed for lot 46997un21 and did not identify other complaints similar to this issue.A review of tracking and trending identified a trend for the list number 7p57 for falsely elevated controls/patient results; review determined that none of the tickets which represented the identified trend are similar to this complaint issue (elevated patient results with repeat results that are lower and quality control is in range) and this trend was determined to not represent a product deficiency.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 07p57-30, lot number 46997un21 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: 12391376
• MDR Text Key: 277709326
• Report Number: 3002809144-2021-00533
• 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
• Report Date: 10/21/2021

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: 07/21/2022
• Device Model Number: 07P5720
• Device Catalogue Number: 07P57-30
• Device Lot Number: 46997UN21
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01534.; ALNTY C PROCESSING MODU, 03R67-01, AC01534.