MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C PHOSPHORUS

Catalog Number	08P40-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated alinity c phosphorus result for 1 sample.The following data was provided (units of measure = mmol/l, reference range = 0.74-1.52 mmol/l): initial result = 3.22, repeat = 1.23.No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device lot number 86490un18 was added in section d of this report.A review of tracking and trending did not identify an increase in complaint activity for falsely elevated patient results and no trends were identified for the issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity c phosphorus assay was identified.

• Brand Name: ALINITY C PHOSPHORUS
• Common Device Name: PHOSPHORUS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8813291
• Report Number: 3002809144-2019-00462
• Device Sequence Number: 16962140
• Product Code: CEO
• UDI-Device Identifier: 00380740135126
• UDI-Public: 00380740135126
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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: 01/06/2020
• Device Catalogue Number: 08P40-20
• Device Lot Number: 86490UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/23/2019
• 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: ALINITY C PROCESSING MODULE, SERIAL (B)(4); ALINITY C PROCESSING MODULE, SERIAL (B)(4); LIST 03R67-01; LIST 03R67-01