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
All available patient information has been included.No additional patient information is available.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false elevated calcium result when processing on the architect c16000.The initial result was 4.2023 mmol/l and retest was 2.2475 mmol/l.The customer uses a reference range of 2.10-2.55 mmol/l.An archived specimen (with an initial result of 3.2538 mmol/l) was retested with consistent results as the retest result was 3.2916 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation was performed for the customer issue and included a review of the complaint text, search for similar complaints, a review of trending data, a review of historical performance of lot 32860un18, review of patient data, and a review of product labeling.A search by lot number identified two other similar complaints that were not a deficiency.The trend review determined there are no adverse trends or non-statistical trends related to this issue.World wide data was used to evaluate the historical performance of lot 32860un18.Patient data was evaluated and indicated the patient median result for lot 32860un18 is within established control limits and no unusual lot performance was identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8608163
• Report Number: 1628664-2019-00376
• Device Sequence Number: 1998092
• 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): 05/31/2019

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: 05/12/2019
• Device Catalogue Number: 03L79-31
• Device Lot Number: 32860UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 05/31/2019
• 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 C16000, LIST 03L77-01; ARCHITECT C16000, LIST 03L77-01; SERIAL (B)(4); SERIAL (B)(4); ARCHITECT C16000, LIST 03L77-01; SERIAL (B)(4)