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	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a falsely depressed architect calcium result.The customer uses a normal range of 8 to 10 mg/dl.On (b)(6) 2022 sample id (b)(6) generated an initial result of 3.4 mg/dl, which was inconsistent with the patient's previous result of (b)(6) mg/dl.The sample was repeat twice and generated (b)(6) and (b)(6) mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier = (b)(6).No further information was provided.
Additional Manufacturer Narrative
Investigation of the complaint issue included review of the complaint details, complaint activity, trending reports, device history records and labeling.Return testing was not completed as returns were not available.The customer determined there were bubbles on the surface of the specimen, indicating a possible pre-analytical condition may have caused the initial low result.Review of complaint activity and trending data did not identify any issues or trends.Review of device history records did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the complaint issue.Based on this investigation, no systemic issue or deficiency were identified for the architect calcium assay.
Event or Problem Description
The customer obtained a falsely depressed architect calcium result.The customer uses a normal range of 8 to 10 mg/dl.On (b)(6) 2022 sample id (b)(6) generated an initial result of 3.4 mg/dl, which was inconsistent with the patient's previous result of 9.5 mg/dl.The sample was repeat twice and generated 9.9 and 9.9 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14104255
• Report Number: 3002809144-2022-00129
• Device Sequence Number: 6229516
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 05/19/2022

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 Expiration Date: 09/21/2022
• Device Model Number: 3L79-22
• Device Catalogue Number: 03L79-22
• Device Lot Number: 61446UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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 C8 PROC MOD, 01G06-11, C804394; ARC C8 PROC MOD, 01G06-11, C804394
• Patient Sex: Unknown