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 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

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 several patients.The results provided were: on (b)(6) 2020 pid (b)(6) initial alinity calcium result=4.61 mmol/l/ repeated=2.53 mmol/l.There was no reported impact to patient management.

Manufacturer Narrative

A ticket search was performed for the alinity c calcium, reagent lot number 38349un20.An investigation was performed for the customer issue and included a review of the complaint text, a search for tracking and trending, a review of historical performance and product labeling.The ticket search determined that there is normal complaint activity for the likely cause 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 lot number 38349un20 was identified.

Manufacturer Narrative

Upon review, it was discovered that an additional concomitant product was omitted on the previous submission.Section d10: new concomitant product: was updated to include alnty c processing modu, 03r67-01 ac03151.

• 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: 10824382
• MDR Text Key: 241306334
• Report Number: 3002809144-2020-01105
• 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,Followup
• Report Date: 09/09/2021

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: 10/23/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 01/07/2021; 09/03/2021
• Supplement Dates FDA Received: 01/07/2021; 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AC03151; ALNTY C PROCESSING MODU, 03R67-01, AC03150; ALNTY C PROCESSING MODU, 03R67-01, AC03150; ALNTY C PROCESSING MODU, 03R67-01, AC03150