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

Model Number IMMULITE 2000 ACTH

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

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

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer.The hsc specialist indicated that acth assay measures intact acth by using antibodies directed against the c and n terminal peptide sequences.The cross-reactivity between the intermediate peptides is not expected.The cause of the discordant, falsely elevated acth results is unknown.

Event Description

A discordant, falsely elevated adrenocorticotropic hormone (acth) result was obtained on one patient sample on an immulite 2000 xpi instrument, when using reagent kit 291.A new sample was obtained from the patient and was tested on an alternate site where it was run on another immulite 2000 instrument, also resulting elevated.The patient also had previous acth testing performed on an unknown platform on (b)(6) 2016 and both the results were elevated.The patient had undergone imagiology examination due to the discordant results and the imagiology examination results were normal.The discordant results were reported to the physician(s) and questioned due to the normal imagiology results.It is unknown if the corrected result was reported to the physician(s).There were no reports of adverse health consequences due to the discordant, falsely elevated acth results.

Manufacturer Narrative

The initial mdr 2432235-2016-00636 was filed on october 19, 2016.Corrected information (10/20/2016): section of the initial mdr states that model # is immulite 2000 psa.The correct model # is immulite 2000 acth.Section has been updated with this information.

• Brand Name: IMMULITE 2000 ACTH
• Type of Device: IMMULITE 2000 ACTH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6041815
• MDR Text Key: 57925174
• Report Number: 2432235-2016-00636
• Device Sequence Number: 1
• Product Code: CKG
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 ACTH
• Device Catalogue Number: L2KAC2
• Device Lot Number: 291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• 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: 57 YR