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	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated calcium results on the architect c16000 processing module.Two examples were provided.Sid (b)(4) 15.6 mg/dl (c16000), 9.63 mg/dl (c8000), sid (b)(4) 16.3 mg/dl (c16000), 9.47 mg/dl (c8000), normal range: 8.4 to 10.2 mg/dl.No adverse 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.All available patient information was included.Additional patient details are not available.Patient identifier for the second sample is (b)(6).
Additional Manufacturer Narrative
The complaint investigation for falsely elevated 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 did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 90112un21 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the calcium assay for lot 90112un21 was identified.Section a: patient identifier for the second sample is (b)(6).
Event or Problem Description
The customer observed falsely elevated calcium results on the architect c16000 processing module.Two examples were provided.Sid (b)(6): 15.6 mg/dl (c16000), 9.63 mg/dl (c8000).Sid (b)(6): 16.3 mg/dl (c16000), 9.47 mg/dl (c8000).Normal range: 8.4 to 10.2 mg/dl.No adverse 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: 14361121
• Report Number: 3002809144-2022-00171
• Device Sequence Number: 19869307
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: 00380740161507
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 07/21/2022
• Device Model Number: 3L79-32
• Device Catalogue Number: 03L79-32
• Device Lot Number: 90112UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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 C16K PRC MOD, 03L77-01, C1600177; ARC C16K PRC MOD, 03L77-01, C1600177
• Patient Sex: Unknown