MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CALCIUM

Catalog Number	03L79-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Patient information: no further patient information was provided.
Event or Problem Description
The customer reported falsely elevated architect calcium results for a (b)(6) year old female patient.The sample generated architect results of 3.09, 3.96 and 3.17 mmol/l.The sample was retested on the mindray bs-2000m and generated normal results of 2.71 and 2.74 mmol/l.The sample was recentrifuged and retested on the architect generating 2.53 and 2.60 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Architect c1600 was corrected to architect c16000.Review of complaint activity for reagent lot 15805un17 identified other complaints related to erratic results.However, tracking and trending report review for the architect calcium assay determined that there were no related trends.Review of the complaint text and results associated with the questioned sample found consistent results were obtained after the sample was re-centrifuged and controls were in range.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect calcium assay was identified.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8918398
• Report Number: 1628664-2019-00580
• Device Sequence Number: 13910500
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (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): 11/15/2019

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: 02/27/2019
• Device Catalogue Number: 03L79-31
• Device Lot Number: 15805UN17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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: ARCHITECT C1600, LIST 03L77-01,; ARCHITECT C16000, LIST 03L77-01,; SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 7 YR