MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE/IMMULITE 1000 ANTI-TG AB

Model Number IMMULITE/IMMULITE 1000 ANTI-TG AB

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

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

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and stated that they ran quality control prior to running the patient sample, which was acceptable.A siemens headquarters support center specialist stated that the immulite 1000 anti-tg ab instructions for use has no claims for correlation of the immulite 1000 results with the results obtained on the alternate platform.The cause of the discordant anti-tg ab result on one patient sample is unknown.Siemens is investigating the issue.

Event Description

The customer obtained a discordant result for anti tg (thyroglobulin) autoantibodies (anti-tg ab) on one patient sample when run on an immulite 1000 instrument, while using reagent lot 0260.The result obtained on the immulite 1000 instrument was interpreted to be nondetectable for thyroglobulin antibodies.The sample was repeated on an alternate platform, resulting different from that obtained on the immulite 1000 instrument.The result obtained on the alternate platform was interpreted as detectable for thyroglobulin antibodies.The result obtained on the immulite 1000 instrument was reported to the physician(s), who questioned it.The correct result obtained on the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant anti-tg ab result.

Manufacturer Narrative

The initial mdr 2432235-2017-00279 was filed on april 21, 2017.Additional information (05/02/2017): upon further investigation, a siemens headquarters support center (hsc) specialist stated that the differences in antigens, antibodies, assay architecture, and assay standardizations can cause differences between results with different manufacturer's assays.The cause of the discordant anti-tg ab result on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is required.

• Brand Name: IMMULITE/IMMULITE 1000 ANTI-TG AB
• Type of Device: IMMULITE/IMMULITE 1000 ANTI-TG AB
• 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: 6513151
• MDR Text Key: 73563485
• Report Number: 2432235-2017-00279
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE/IMMULITE 1000 ANTI-TG AB
• Device Catalogue Number: LKTG1
• Device Lot Number: 0260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• 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: 31 YR