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	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was previously reported under manufacture report number 1415939-2017-00110.The incorrect manufacture location was selected in the initial report.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling.Based on the available data, it appears that a sample aspiration issue was present.A review of tracking and trending did not identify an adverse trend for issue observed by the customer.No other similar complaints were identified with this reagent lot number.Labeling was reviewed and found to be adequate.Based on this investigation this appears to be a sample specific issue.Based on the available information no deficiency of the clinical chemistry calcium assay, reagent list number 03l79, lot 36253un16, was identified.
Event or Problem Description
The customer observed falsely decreased clinical chemistry calcium results.The customer provided the following results (customer provided range 8.3-10.0): sid (b)(6): initial 0.8 mmol/l, retested on a different analyzer: 2.25 mmol/l.The results were not reported from the laboratory.There was no impact to patient management 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: 6657972
• Report Number: 1628664-2017-00267
• Device Sequence Number: 13793199
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: (01)00380740005948(17)171219(10)36253UN16
• 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
• Report Date (Section B): 06/21/2017

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: 12/19/2017
• Device Catalogue Number: 03L79-31
• Device Lot Number: 36253UN16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1