MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the customer issue included a review of the complaint text, a search for similar complaints and a review of labeling.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the calcium reagent.Labeling was reviewed and found to be adequate.The on-site servicing of the architect and the customer's diligence in maintenance documentation tend to minimize the possibility the instrument is the likely cause.In addition, qc appears to not be affected.Based on the available information, no product deficiency was identified.
Event or Problem Description
The customer observed intermittent discrepant calcium results for patient samples tested on the architect c8000.An initial result of 14.7 mg/dl (critical high) retested at 9.7 mg/dl (normal).No adverse impact to patient management was reported.
Additional Manufacturer Narrative
After further troubleshooting of the customer issue, the suspect medical device was changed from clinical chemistry calcium reagent, list 03l79-30 to the architect c8000 system, list 01g06-11 on (b)(6) 2017.Mdr number 1628664-2017-00397 has been submitted for the new suspect medical device and all further information will be documented under that mdr number.
Additional Manufacturer Narrative
Additional discrepant architect calcium results were observed for a patient on (b)(6) 2017.Results of 10.1, 10.2 and 14.1 mg/dl were generated.The customer uses a normal range of 8.4 - 10.2 mg/dl.No impact to patient management was reported.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6897313
• Report Number: 1628664-2017-00359
• Device Sequence Number: 898652
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Medical Technologist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2017

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: 03/12/2018
• Device Catalogue Number: 03L79-30
• Device Lot Number: 36256UN16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/30/2017; 10/05/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 10/04/2017; 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1