MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) CALCIUM

Model Number	3L79-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id of multiple is (b)(6).The evaluation is in process.A follow up report will be submitted when evaluation is complete.Evaluation is in process.
Event or Problem Description
The account generated false depressed architect calcium results on multiple samples that repeated higher.Id (b)(6) tested 5.88 but repeated 8.77 mg/dl on (b)(6) 2020.Id (b)(6)tested 6.02 but repeated 9.26, 9.33 mg/dl on (b)(6) 2020.Id (b)(6) tested 5.93 but repeated 8.64 mg/dl on (b)(6) 2020.Id (b)(6) tested 3.90 but repeated 9.0 mg/dl on (b)(6) 2020.Id (b)(6) tested 4.75 but repeated 8.98 mg/dl on (b)(6) 2020.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 19417un19.Trending review determined no adverse trend for falsely depressed results for the product.World wide data was reviewed and determined that the patient median result for lot 19417un19 is comparable with other lots in the field.Return testing was not completed as returns were not available.A precision run using both patient samples and quality control passed after maintenance was performed at the customer site and results were as expected.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or product deficiency of the architect calcium reagent, lot number 19417un19 was identified.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9955523
• Report Number: 3016438761-2020-00034
• Device Sequence Number: 2900615
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 05/28/2020

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: 07/09/2020
• Device Model Number: 3L79-21
• Device Catalogue Number: 03L79-21
• Device Lot Number: 19417UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 05/28/2020
• 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 C8000 LIST 1G06-11; ARCHITECT C8000 LIST 1G06-11; SERIAL (B)(6) ; SERIAL (B)(6)