MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY PHOSPHORUS

Model Number	7D71-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of complaint tracking and trending metrics was performed and identified no adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation.No non-conformances were identified associated with the customer observations.There were no returns made available from the customer site.A review of the architect c8000 analyzer instrument logs was performed and only the morning and repeat sample results could be found.There were however, 28 occurrences of error code 3375 (unable to process test, aspiration error occurred) (b)(6) 2017.Frequent occurrences of this error code or occurrences with no assignable cause may indicate inadequate centrifugation or sample preparation.The architect clin chem phosphorus assay package insert and the architect system operations manual provide information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, no systemic issue or product deficiency was identified.Use error may have contributed to the customer's issue as error codes indicate pre-analytical sample handling may have contributed to this issue.(b)(6).
Event or Problem Description
The customer reports that one patient (being treated for hypercalcemia and receiving calcitonin / hemofiltered / 24 hours) sample generated the following clin chem phosphorus assay results on an architect c8000 analyzer: (b)(6): 3.87, 2.76, 3.27 and 2.52 mmol/l.The sample was drawn with a heparin collection tube.An additional sample was drawn on this patient later in the day ((b)(6)) and generated results in the range of 1.35-1.83 mmol/l (n=13) also drawn in a heparin collection tube.The customer then ran a sample from this same patient that was drawn in a red top collection tube ((b)(6)).This sample generated results in the range of 0.98-1.27 mmol/l (n=10).The customer uses a normal reference range of 0.74-1.52 mmol/l.The patient is in recovery.No suspect results were reported from the lab.There is no impact to patient management reported.

• Brand Name: CLINICAL CHEMISTRY PHOSPHORUS
• Common Device Name: PHOSPHORUS
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6839718
• Report Number: 1628664-2017-00327
• Device Sequence Number: 660036
• Product Code: CEO
• UDI-Device Identifier: 00380740012946
• UDI-Public: (01)00380740012946(17)171110(10)03267UN16
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K981759
• 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): 09/01/2017

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: 11/10/2017
• Device Model Number: 7D71-22
• Device Catalogue Number: 07D71-22
• Device Lot Number: 03267UN16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1