MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) ALINITY C CALCIUM REAGENT KIT

Model Number 07P5730

Device Problem High Test Results (2457)

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

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.The complaint investigation for falsely elevated alinity c calcium results included a review of data provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.A review of tickets determined that there is normal complaint activity for alinity c calcium reagent ln 7p57-30/lot number 37978un19.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Review of the capa database found no issue related to the current complaint.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics' complaint investigation, no systemic issue or deficiency of alinity c calcium reagent ln 7p57-30/lot number 37978un19 was identified.The initial report was submitted under manufacturer report number 3002809144-2020-00542 with abbott (b)(4) as the manufacturing site, however, that is the incorrect manufacturing site.The correct manufacturing site is (b)(4), which is this report.

Event Description

The customer observed falsely elevated calcium results for several patients on an alinity c analyzer.The following data was provided (customer's normal range is 8.5-10.5 mg/dl): sample id (b)(6) initial result, on (b)(6) 2020, was 15.3, repeat was 8.1 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.1, repeat was 9.1 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.7, repeat was 9.8 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.4, repeat was 6.5 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 16.0, repeat was 7.8 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.9, repeat was 8.9 mg/dl.There was no impact to patient management reported.

Manufacturer Narrative

The correct manufacturing site for suspect medical device calcium is abbott gmbh max-planck-ring 2 wiesbaden 65205, deu and was submitted under manufacturer report number 3002809144-2020-00542.All further information will be documented under mdr number 3002809144-2020-00542.

• Brand Name: ALINITY C CALCIUM REAGENT KIT
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10525788
• MDR Text Key: 244158726
• Report Number: 3016438761-2020-00210
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: 00380740135409
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

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: 07/23/2020
• Device Model Number: 07P5730
• Device Catalogue Number: 07P57-30
• Device Lot Number: 37978UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE, LIST# 03R67-01,; ALINITY C PROCESSING MODULE, LIST# 03R67-01,; SERIAL# (B)(6).; SERIAL# (B)(6).