MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY PHOSPHORUS

Catalog Number 07D71-22

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier: (b)(6) udi: (b)(4) lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.

Event Description

The customer reports that one patient sample (sid (b)(6)) generated an initial elevated architect clin chem phosphorus assay result of 3.67 mmol/l (11.36 mg/dl).Previously, this patient had generated a result of 0.92 mmol/l (2.8 mg/dl).The sample was then retested with a value of 0.98 mmol/l (3.0 mg/dl).The sample was then tested on another architect system in the lab and generated a result of 1.00 mmol/l (3.1 mg/dl).No suspect results had been reported from the lab.A precision run was performed and met specifications.The sample was inspected and did contain a "high amount of floating fibrin." there is no impact to patient management reported.

Manufacturer Narrative

A review of complaint tracking and trending metrics was performed and identified no related adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation.No non-conformances or deviations were identified.No returns were made available from the customer site.No testing was performed.A review of the architect c16000 analyzer instrument logs was performed.The history log shows numerous (61) occurrences of error code (ec) 3375 (aspiration error) from (b)(6) 2017.The maintenance log from (b)(6) shows the customer only performed as needed maintenance (6052) on february 2nd.The customer discontinued the as needed maintenance (6052) cuvette wash procedure on (b)(6) 2017, prior to the discrepant result on (b)(6) 2017.The architect clinical chemistry phosphorus assay package insert and the architect system operations manual contain information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.Serum and plasma samples, if not spun according to manufacturer's specifications, may generate inaccurate values.It is critical that spin times are not reduced as compensation for higher centrifuge speeds.The device met performance specifications and performed as intended at the customer site.The customer reports inspecting the sample and finding a high amount of floating fibrin in the patient serum sample.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: 6405418
• MDR Text Key: 69957877
• Report Number: 1628664-2017-00070
• Device Sequence Number: 1
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2017
• Device Catalogue Number: 07D71-22
• Device Lot Number: 88136UN16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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: ARCHITECT C16000 ANALYZER LN:03L77-01; SN:(B)(4)