MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 ACTH

Model Number IMMULITE 2000 XPI

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

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

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.There was no indication of an instrument malfunction.The customer stated that the discordant results may have been due to a sample specific issue.The cause of the discordant, falsely elevated acth results on one patient sample is unknown.The instrument is performing within specifications.No further evaluation of device is required.

Event Description

A discordant, falsely elevated adrenocorticotropic hormone (acth) result was obtained on one patient upon initial testing on an immulite 2000 xpi instrument.The discordant result was not reported to the physician(s).The sample was repeated on an alternate platform, resulting lower.A second tube was obtained from the patient and was tested neat and with dilution (1:2 dilution factor) on the immulite 2000 xpi instrument, resulting elevated.Sample from the second tube was then tested in a tube treated with polyethylene glycol (peg), a non-specific antibody blocking tube (nabt) and a heterophilic blocking tube (hbt) and run on the immulite 2000 xpi instrument.No result was obtained from the peg tube as the sample was viscous.The results from the nabt and hbt were still elevated.The corrected result obtained on the alternate platform was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated acth results.

Manufacturer Narrative

The initial mdr 2247117-2017-00010 was filed on january 30, 2017.Additional information (02/13/2017): a siemens headquarters support center (hsc) specialist reviewed the data provided by the customer and stated that the differences between the results obtained when the sample was run neat, diluted and when treated with non-specific antibody blocking tube are indicative of the presence of non-specific antibody interference.Corrected information (02/13/2017): updated with the correct product information.

• Brand Name: IMMULITE 2000 ACTH
• Type of Device: IMMULITE 2000 ACTH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd NJ LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd NJ LL55 4EL; UK LL55 4EL
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6287868
• MDR Text Key: 66140608
• Report Number: 2247117-2017-00010
• Device Sequence Number: 1
• Product Code: CKG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K960066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 XPI
• Device Lot Number: 294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR