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 Consequences Or Impact To Patient (2199)
Date of Event	02/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be provided when the evaluation is complete.
Event or Problem Description
The customer indicated that discrepant calcium results were generated on the architect c16000 analyzer.A patient sample generated an initial result of 1.42 mmol/l.The sample was repeated and a result of 2.43 mmol/l was generated.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Date received by manufacturer was updated from the initial report of 03feb2017 to the correct awareness date of 13feb2017.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The customer performed troubleshooting on the instrument which included replacement of the cuvette dryers, checked the alignment of the dryers and ran contamination test which showed no sign of contamination.Field service visited the site and found needle 1 a of the cuvette washer bent.The 5 needles and mixers were adjusted, checked cuvette wash and membranes of the vacuum pump and no issues were found.The customer reported the false depressed calcium result after instrument troubleshooting was performed, therefore the architect calcium assay was determined to be the likely cause of the result issue.A search for similar complaints did not identify an increase in complaint activity.Additionally, no adverse or non-statistical trends were identified.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the evaluation the architect calcium assay is performing acceptably.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6354399
• Report Number: 1628664-2017-00044
• Device Sequence Number: 10907274
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2017

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: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 02/24/2017; 04/07/2017
• 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 LIST 03L77-01 SERIAL (B)(4)