MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Model Number	3L79-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier of multiple is ids: (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.
Event or Problem Description
The account generated falsely elevated architect calcium results on patient samples that repeated in the normal range.Examples were provided of 23 patients samples with elevated architect calcium ranging 15.8 to 14.8 mg/dl that repeated in the normal range of 8.4 to 10.2 mg/dl.No impact to patient management was reported.No specific patient information was provided.
Additional Manufacturer Narrative
Date of event updated from initial report of (b)(6) 2018 to the correct date of (b)(6) 2018.The customer stated the issue was resolved after recalibrating the new reagent cartridge using the same calibrator lot used before.A review of the customer data showed patient samples were running >15 mg/dl on the new reagent pack but after calibration of this pack, the patient samples were back within normal range.The result log from (b)(6) 2018 was reviewed.When the customer switched to another cartridge on (b)(6) 2018, the quality control were extremely low (out of range).The customer had to recalibrate this reagent cartridge and the qc returned to expected range.This demonstrated that the issue for the >15 mg/dl obtained on (b)(6) 2018, is most likely due to a reagent cartridge that had been compromised.The customer was able to used it successfully by recalibrating.The recalibration reset the baseline and the patient results came back within normal range.But when another new cartridge was used with the calibration from the compromised cartridge, the results were extremely low (qc).By recalibrating this new cartridge, the customer was able to reset back the baseline for the calcium assay.A review for similar complaints was performed with a complaint search by reagent lot 45322un17 with no other complaints identified.A review of the product labeling concluded that the issue is sufficiently addressed.A review was performed for adverse trends for calcium reagent.This review found no adverse trend reports during the past 12 months.A review was performed for non-statistical trends for calcium reagent during the past 12 months to detect any significant complaint increases in the monthly rate related to this issue.No non-statistical trends were identified.A review of non-conformances for the past 12 months found no non-conformances or deviations for calcium reagent.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: 7339675
• Report Number: 1628664-2018-00112
• Device Sequence Number: 1144466
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: (01)00380740005948(17)181027(10)45322UN17
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/19/2018

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: 10/27/2018
• Device Model Number: 3L79-31
• Device Catalogue Number: 03L79-31
• Device Lot Number: 45322UN17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1