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

Model Number	3L79-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
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.No additional patient information is available.
Event or Problem Description
The customer generated falsely depressed calcium results for one patient while using the architect c8000 processing module.The customer's normal range is 2.1 - 2.6 mmol/l.The following information was provided: sid (b)(6) 2021 initial result 0.68 mmol/l repeated 2.4 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
H6 health effect impact code: f26.Component code: g03001.D8 was this device serviced by a third party? no.A review of tickets was performed for reagent lot number 33580un20.The ticket search determined that there is normal complaint activity for the reagent 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 architect calcium reagent assay for lot 33580un20 was identified.
Additional Manufacturer Narrative
It was identified in supplemental report 3016438761-2021-00064-02 that supplemental report 3016438761-2021-00064-01 inadvertently used the incorrect component code; the code g03001 was inadvertently selected in 3016438761-2021-00064-01 (and subsequently entered into the component code field on 3016438761-2021-00064-02.The code g01003 is the correct code.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: CALCIUM
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11388648
• Report Number: 3016438761-2021-00064
• Device Sequence Number: 17175195
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2021

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 Expiration Date: 05/05/2021
• Device Model Number: 3L79-21
• Device Catalogue Number: 03L79-22
• Device Lot Number: 33580UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/26/2021; 06/22/2021; 06/22/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/03/2021; 06/22/2021; 06/22/2021
• 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 C8 PROC MOD, 01G06-11, C803764; ARC C8 PROC MOD, 01G06-11, C803764; ARC C8 PROC MOD, 01G06-11, C803764; ARC C8 PROC MOD, 01G06-11, C803764