MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Model Number	3L79-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.There is no further patient information provided by the customer.
Event or Problem Description
The customer reported falsely decreased calcium (ca) results on one patient.The results provided were: initial draw = 1.39mmol/l / repeat = 1.38mmol/l / new draw same day = 2.25mmol/l / retest of original sample = 2.32mmol/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets determined that there were no similar complaints for lot 20039un17 identified.The tracking and trending report review determined that there were no trends identified.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the calcium reagent package insert provides information on reagent handling, and how it could impact results.The architect system operations manual provides guidance for assay results in regards to symptoms, other test results, clinical impressions and other diagnostic procedures that must be considered for patient care management.It also provides information for maintaining optimal system performance and probable causes and corrective actions for erratic results, poor precision and error codes.Based on the investigation no product deficiency was identified for the clin chem calcium reagent, lot 20039un17.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7573682
• Report Number: 1628664-2018-00222
• Device Sequence Number: 16583075
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: (01)00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/06/2018

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: 07/18/2018
• Device Model Number: 3L79-21
• Device Catalogue Number: 03L79-21
• Device Lot Number: 20039UN17
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 09/06/2018
• 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 SYSTEM, LIST # 03L77-01,; ARCHITECT C16000 SYSTEM, LIST # 03L77-01,; SERIAL # (B)(4); SERIAL # (B)(4)
• Patient Age: 61 YR