MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CALCIUM

Catalog Number	03L79-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely depressed calcium result generated on the architect analyzer for 1 patient.The following data was provided (units of measure = mg/dl, reference range = 8.4 to 10.2 mg/dl): on (b)(6) 2019 sid (b)(6) initial result = 2.2, repeat = 9.5.No impact to patient management was reported.
Additional Manufacturer Narrative
It was discovered on october 04, 2019 that the initial and follow-up-01 emdr for this issue was submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 1628664-2019-00652 has been submitted for the correct manufacturing site and all further information will be documented under that mdr number.
Additional Manufacturer Narrative
A ticket search was performed for the reagent lot number 04770un19.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the calcium assay was identified.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038 3500
• MDR Report Key: 8959348
• Report Number: 1415939-2019-00187
• Device Sequence Number: 2688357
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2019

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: 06/07/2020
• Device Catalogue Number: 03L79-21
• Device Lot Number: 04770UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/20/2019; 10/04/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/25/2019; 10/07/2019
• 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 C8000 ANALYZER, LIST 1G06-11; ARCHITECT C8000 ANALYZER, LIST 1G06-11; ARCHITECT C8000 ANALYZER, LIST 1G06-11; SERIAL (B)(4); SERIAL (B)(4); SERIAL (B)(4)