MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY PHOSPHORUS

Catalog Number 07D71-31

Device Problem Incorrect Measurement (1383)

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

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reports discrepant clin chem phosphorus assay results generated on an architect c16000 analyzer.The following examples were provided: sid (b)(6)= 4.1 and 12.0 mg/dl; sid (b)(6)= 4.1 and 14.0 mg/dl.Controls were within specification.No suspect results were reported from the lab.There is no impact to patient management reported.

Manufacturer Narrative

A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.A review of the instrument logs shows 63 occurrences of (b)(4).Promptly perform the wash cuvettes procedure).Use error may have contributed to the customer's issue as these error codes indicate the instrument may have dirty cuvettes, which could affect the optical readings.The architect clin chem phosphorus assay package insert contains information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, a product malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, no systemic issue or product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY PHOSPHORUS
• Type of Device: PHOSPHORUS
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6460883
• MDR Text Key: 72098759
• Report Number: 1628664-2017-00091
• Device Sequence Number: 1
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K981759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2017
• Device Catalogue Number: 07D71-31
• Device Lot Number: 88137UN16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LN: 03L77-01 SN: (B)(4)