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

Model Number	3L79-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
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.
Event or Problem Description
The customer observed a falsely depressed calcium result generated on the architect c16000 processing module for one sample.Results provided: (customer range 8.4-10.2 mg/dl).Sid (b)(6) initial result 5.9 mg/dl, repeated on another instrument 9.4 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed calcium results 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.Return testing was not completed as returns were not available.Trending review by did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with list number 03l79 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.As part of troubleshooting, the samples was retested on another analyzer and gave higher normal results.Additionally, a clog in the high concentration waste line was discovered, indicating a possible pre-analytical condition may have caused the initial low result.Based on our investigation, no systemic issue or deficiency with the calcium assay for unknown lot was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14850597
• Report Number: 3002809144-2022-00225
• Device Sequence Number: 16739177
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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: 3L79-22
• Device Catalogue Number: 03L79-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/29/2022
• 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 C16K REFURB-SEKAT, 03L77-97, (B)(6) ; ARC C16K REFURB-SEKAT, 03L77-97, (B)(6)
• Patient Sex: Unknown