MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY PHOSPHORUS

Catalog Number	07D71-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided further investigation of the customer issue included a review of the complaint data, a search for similar complaints, and a review of labeling.Return material was not available.Tracking and trending did not identify an adverse.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the clinical chemistry phosphorus assay, list number 07d71, lot 91772un16, was identified.
Event or Problem Description
The customer observed falsely decreased clinical chemistry phosphorus results for five patients.The customer indicated they were generating results of <0.7 mg/dl for each patient, the retest was within range.Initial and retest results for four of the five patients was provided as follows: on (b)(6) 2016: initial <0.7 mg/dl, retested on (b)(6) 2016 on a second analyzer: 2.0 mg/dl sid (b)(6) initial <0.7, retest 1.8 mg/dl; sid (b)(6) initial <0.7, retest 2.0 mg/dl; sid (b)(6) initial <0.7, retest 2.0 mg/dl.(customer normal patient range 2.3 - 4.7 mg/dl).There was no adverse 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: 6541452
• Report Number: 1628664-2017-00175
• Device Sequence Number: 16167318
• Product Code: CEO
• UDI-Device Identifier: 00380740012953
• UDI-Public: 00380740012953
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K981759
• 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
• Report Date (Section B): 05/03/2017

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: 03/12/2017
• Device Catalogue Number: 07D71-31
• Device Lot Number: 91772UN16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/03/2017
• 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 C8000 SYSTEM, LN01G06-11, SN (B)(4)