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

Model Number 07P5730

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = sid= (b)(6).All available patient information was included.Additional patient details are not available.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 one patient.The results provided were: on (b)(6) 2020 sid (b)(6) initial calcium on alinity (b)(4) =15.2 mg/dl/repeated=10.1 mg/dl, 10.5 mg/dl, 10.4 mg/dl.Repeated on alinity (b)(4) =12.7 mg/dl /repeated on alinity (b)(4) =9.8 mg/dl, 10.2 mg/dl, 9.9 mg/dl.The precision data provided for troubleshooting purpose and not used for patient management.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets found three similar complaint for alinity c calcium lot 38349un20, but no trends were identified for falsely elevated results or by the product list number.Return testing was not completed as returns were not available.Retesting of samples gave expected results on the same and another instrument at customer site.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity c calcium reagent, lot 38349un20.

• 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: 11038013
• MDR Text Key: 241307062
• Report Number: 3002809144-2020-01194
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: 00380740135409
• 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: 01/19/2021

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: 03/23/2021
• Device Model Number: 07P5730
• Device Catalogue Number: 07P57-30
• Device Lot Number: 38349UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC03216; ALNTY C PROCESSING MODU, 03R67-01, AC03216