MAUDE Adverse Event Report: KYOWA MEDEX CO., LTD. (JAPAN) FOR: ADVIA CENTAUR XP INSULIN (IRI) ASSAY; INSULIN IMMUNOASSAY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

The reagents were checked by the customer.There were no visible clumps.The quality control (qc) and the calibrations were acceptable.The field service engineer (fse) verified the hardware performance and found all data satisfactory.The field application specialist (fas) also performed other precision checks and sample correlations for the insulin (iri) assay.All the data was satisfactory.The cause for the discordant advia centaur xp insulin (iri) result is unknown.Pre- analytical factors may be the possible cause of the discordant result.The instrument is performing within specification.No further evaluation of the device is required.The ifu states on the interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

A falsely elevated advia centaur xp insulin (iri) result was obtained on a patient sample.The patient sample was repeated and the result was elevated.The physician sent the patient sample to another laboratory ((b)(6) lab) to be tested on an alternate platform.The result was lower.The same sample was tested at another location ((b)(6)) on the advia centaur xp and the result was similar to the alternate platform.The sample was then tested at the customer site on the advia centaur xp and the result was similar to the alternate platform.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the insulin (iri) discordant results.

• Brand Name: ADVIA CENTAUR XP INSULIN (IRI) ASSAY
• Type of Device: INSULIN IMMUNOASSAY
• Manufacturer (Section D): KYOWA MEDEX CO., LTD. (JAPAN) FOR:; siemens healthcare diagnostics; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 5910301
• MDR Text Key: 54276213
• Report Number: 1219913-2016-00153
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2016
• Device Model Number: N/A
• Device Catalogue Number: 02230141
• Device Lot Number: 164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR