MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 ANTI-TG AB

Model Number IMMULITE 2000 ANTI-TG AB

Device Problems Device Ingredient or Reagent Problem (2910); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist and reported that imprecise quality control and patient results were obtained while using kit lot 643.The customer stated that they switched to kit lot 649 from 643.Quality control and patient results obtained on kit lot 649 were consistent.The cause of the imprecise anti-tg ab results on multiple patient samples is unknown.Siemens is investigating the issue.

Event Description

Imprecise autoantibodies to thyroglobulin (ant-tg ab) results were obtained on multiple patient samples upon initial and repeat testing on an immulite 2000 xpi instrument.The customer reported the mean of the results for each patient to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the imprecise anti-tg ab results.

Manufacturer Narrative

The initial mdr 2247117-2016-00073 was filed on november 2, 2016.Additional information (11/14/2016): the customer stated that moving from kit lot 643 to 649 resolved the issue.

Manufacturer Narrative

The initial mdr 2247117-2016-00073 was filed on november 2, 2016.The first supplemental mdr 2247117-2016-00073 was filed on december 13, 2016.Additional information (01/18/2017): a siemens headquarters support center specialist reviewed the patient data provided by the customer.The bias for kit lot 643 vs.Kit lot 637 and 649 were acceptable.The cause of the imprecise anti-tg ab results on multiple patient samples is unknown.

Manufacturer Narrative

The initial mdr 2247117-2016-00073 was filed on november 2, 2016.The first supplemental mdr 2247117-2016-00073_s1 was filed on december 13, 2016.The second supplemental mdr 2247117-2016-00073_s2 was filed on january 23, 2017.Additional information (03/09/2017): siemens technical support laboratory performed in-house testing on five samples ranging between 40 - 800 iu/ml for anti-tg ab assay on an immulite 2000 instrument using kit lot 643.Two of five samples passed precision testing (within run coefficient of variation and total coefficient of variation).Two of five samples failed both within run coefficient of variation and total coefficient of variation.One of five samples passed within run coefficient of variation and failed total coefficient of variation.Corrected information (03/09/2017): evaluation in progress).Siemens is investigating the issue.

Manufacturer Narrative

The initial mdr 2247117-2016-00073 was filed on november 2, 2016.The first supplemental mdr 2247117-2016-00073_s1 was filed on december 13, 2016.The second supplemental mdr 2247117-2016-00073_s2 was filed on january 23, 2017.The third supplemental mdr 2247117-2016-00073_s3 was filed on april 3, 2017.Additional information (06/14/2017): upon further investigation, siemens has confirmed the customer's findings.

Manufacturer Narrative

The initial mdr 2247117-2016-00073 was filed on november 2, 2016.The first supplemental mdr 2247117-2016-00073_s1 was filed on december 13, 2016.The second supplemental mdr 2247117-2016-00073_s2 was filed on january 23, 2017.The third supplemental mdr 2247117-2016-00073_s3 was filed on april 3, 2017.The fourth supplemental mdr 2247117-2016-00073_s4 was filed on june 28, 2017.The fifth supplemental mdr 2247117-2016-00073_s5 was filed on november 6, 2017.Corrected information (11/29/2017): 2247117-2016-00073_s5 stated that the additional and corrected information was provided on october 12, 2017.The correct notification date is november 6, 2017.Date rec¿d by mfr cannot be updated with this information as it is being used for this report.

Manufacturer Narrative

Additional information (10/12/2017): the outcome of the siemens internal studies has shown that although the assay is resulting in higher precision values then the representative precision data in the immulite systems autoantibodies to thyroglobulin (anti-tg ab) instructions for use (ifus), it is performing as designed and is meeting the design acceptance criteria for the intra-assay precision for all samples tested.All of the immulite systems platforms met their respective design goals for the intra-assay precision.There are no design goals for the inter-assay precision for the immulite/immulite 1000 and the immulite 2000/immulite 2000xpi anti-tg ab assay.While numerical differences were observed for intra-assay and inter-assay precision performance between the internal investigation and the ifu claims, the differences would not be considered clinically relevant and would not impact the utility of the assay.All design input requirements (dir) for intra-assay precision were met.All in date kits for the immulite/immulite 1000 and the immulite 2000/immulite 2000xpi anti-tg ab assay are meeting their intended clinical use.The device is performing within manufacturing specifications.No further evaluation of device is required.

• Brand Name: IMMULITE 2000 ANTI-TG AB
• Type of Device: IMMULITE 2000 ANTI-TG AB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd; flanders 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: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 6073152
• MDR Text Key: 59024979
• Report Number: 2247117-2016-00073
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K991094
• 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,Followup,Followup,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 ANTI-TG AB
• Device Lot Number: 643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2017
• 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