MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C PHOSPHORUS

Catalog Number 08P40-20

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2019

Event Type  malfunction  

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 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.

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
• Type of Device: PHOSPHORUS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8813291
• MDR Text Key: 152091172
• Report Number: 3002809144-2019-00462
• Device Sequence Number: 1
• Product Code: CEO
• UDI-Device Identifier: 00380740135126
• UDI-Public: 00380740135126
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2020
• Device Catalogue Number: 08P40-20
• Device Lot Number: 86490UN18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE, SERIAL (B)(4); ALINITY C PROCESSING MODULE, SERIAL (B)(4); LIST 03R67-01; LIST 03R67-01