MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
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.Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.An evaluation is in process.
Event or Problem Description
The customer observed a falsely low calcium result generated using clinical chemistry calcium reagents.The following data was provided.The customer uses normal range 8.7 to 10.4 mg/dl.Initial 5.1, repeat 9.7.No impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included complaint text review, a search for similar complaints, instrument log review, and labeling review.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Instrument log review found that the patient sample was scheduled for other assays and results of other tests included error code 3375 aspiration error during sampling.However, the calcium test was not scheduled at the same time the error code was generated and calcium results did not include the same error code.Review of the test data indicated the sample volume was lower than adequate to complete scheduled tests.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6382193
• Report Number: 1628664-2017-00057
• Device Sequence Number: 779907
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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: 10/11/2017
• Device Catalogue Number: 03L79-31
• Device Lot Number: 82308UN16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 04/04/2017
• 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 ANALYZER; LIST NUMBER 03L77-01; SERIAL NUMBER (B)(4)