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

Model Number 3L79-22

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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 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
• Type of Device: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12393540
• MDR Text Key: 269000628
• Report Number: 3002809144-2021-00540
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• Combination Product (y/n): N
• PMA/PMN Number: K062855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1