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	02/25/2019
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.
Event or Problem Description
The customer reported a discrepant calcium result when processing on the architect c16000.The initial result was 19.1 mg/dl and retest 9.3 mg/dl, for sid (b)(6).The customer uses a normal range of 8.7-10.3 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
This product is no longer considered the likely cause for this event.This event has been reported under manufacturer report number 1628664-2019-00257, for the correct likely cause, and any additional information for this event will be provided under this report number.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8449134
• Report Number: 1628664-2019-00256
• Device Sequence Number: 3219157
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 05/03/2019

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 Catalogue Number: 03L79-21
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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 (B)(4), LIST 03L77-01; ARCHITECT (B)(4), LIST 03L77-01; SERIAL (B)(4); SERIAL (B)(4)