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

Model Number	3L79-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
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.
Event or Problem Description
The customer obtained a falsely elevated architect calcium result.The customer's normal range is 8.4 to 10.2 mg/dl.Sample id (b)(6) generated 15.0, 11.8, 11.5 and 9.5 mg/dl.A second sample from the patient generated 9.8 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The investigation of the customer issue included review of the complaint text and information provided by the customer, review of complaint activity, review of trending data, review of labeling and review of device history records, review of field data.Return testing was not completed as returns were not available.Review of trending reports did not identify any trends related to the complaint issue.Device history records review for the reagent lot did not identify any non-conformance or deviations related to the complaint issue.Using worldwide field data the performance of the complaint lot was reviewed.The patient median result for the lot was within the established limits indicating that the lot is performing acceptably.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect calcium assay was identified.
Event or Problem Description
The customer obtained a falsely elevated architect calcium result.The customer's normal range is 8.4 to 10.2 mg/dl.Sample id (b)(6) generated 15.0, 11.8, 11.5 and 9.5 mg/dl.A second sample from the patient generated 9.8 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
• MDR Report Key: 12393540
• Report Number: 3002809144-2021-00540
• Device Sequence Number: 4056694
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/11/2021

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: 01/20/2022
• Device Model Number: 3L79-22
• Device Catalogue Number: 03L79-22
• Device Lot Number: 50854UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1