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

Model Number	3L79-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.A review of tickets by product lot number could not be performed as the lot number was unknown.Although an increase in complaint activity was found associated with the calcium reagent for falsely elevated and shifts in calcium quality control and/or patient results that are due to lot to lot variability and not related to this current complaint issue, which is specific to the documented patient sample.Additionally, the sample when retested, generated a lower normal result and quality control was in range.Also, the customer ran a precision run with 10 replicates of quality control which were all within range, indicating the assay is performing as expected.Precision study when performed using quality control material was less than 3% which was within the assay claim.Samples were repeated from the same day that the discrepant sample was run and no discrepant results were observed for other samples.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations related to the complaint issue for list number 3l79.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the calcium reagent with an unknown lot number was identified.
Event or Problem Description
The customer observed falsely elevated calcium results generated on the architect c4000 analyzer for one sample that the physician questioned.The following data was provided (the customer¿s reference range is 8.5 to 10.5 mg/dl): (b)(6) 2021 sid (b)(6) initial result = (b)(6) mg/dl, repeat = (b)(6) mg/dl.No impact to patient management was reported.

• Brand Name: CALCIUM
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12861602
• Report Number: 3002809144-2021-00670
• Device Sequence Number: 4265958
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: 00380740161507
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 3L79-32
• Device Catalogue Number: 03L79-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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 C4000 INTGR, 02P24-40, C400690
• Patient Sex: Unknown