MAUDE Adverse Event Report: ABBOTT LABORATORIES CALCIUM; AZO DYE, CALCIUM

Model Number 3L79-21

Device Problem High Test Results (2457)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.

Event Description

The customer reported false elevated architect calcium (ca) results for one patient run on two architect analyzers.The customer provided: sid (b)(6) initial = 3.74 mmol/l, repeat = 3.79 mmol/l (normal range: (2.10 to 2.55 mmol/l).Repeats on another analyzer for this same sample: 3.65, 4.66, 3.74, 3.79, 2.53, 2.88, and 2.82 mmol/l.The other values provided from the customer for all results associated with this test were reviewed and none met reportability criteria there was no impact to patient management reported.

Manufacturer Narrative

The evaluation of the customer¿s issue included a search for similar complaints, trending data, labeling, device history records, and historical performance of reagent lot 93249un19.A review of tickets determined that there is normal complaint activity for lot 93249un19.Trending review determined no trend for falsely depressed results for the product.Return testing was not completed as returns were not available.Qc passed at the customer site and results were the same when retested on the instrument.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.No return sample is available for testing.No file sample testing performed as the complaint data and log analysis show this is a sample specific issue.The sample result has been confirmed by retesting.Based on all available information no systemic issue or product deficiency was identified.

• Brand Name: CALCIUM
• Type of Device: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11002251
• MDR Text Key: 221242570
• Report Number: 3016438761-2020-00332
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• 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: 02/05/2021

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 Model Number: 3L79-21
• Device Catalogue Number: 03L79-21
• Device Lot Number: 93249UN19
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8000 PRC MOD, 01G06-01, C801428; ARC C8000 PRC MOD, 01G06-01, C801428; ARC C8000 PRC MOD, 01G06-01, C801428