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

Model Number	3L79-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11002251
• Report Number: 3016438761-2020-00332
• Device Sequence Number: 10957296
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 3L79-21
• Device Catalogue Number: 03L79-21
• Device Lot Number: 93249UN19
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C8000 PRC MOD, 01G06-01, C801428; ARC C8000 PRC MOD, 01G06-01, C801428; ARC C8000 PRC MOD, 01G06-01, C801428