MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRIVATE LIMITED IMMULITE 2000 XPI CALCITONIN

Model Number 10381446

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

An outside the us customer observed depressed immulite 2000 xpi calcitonin results from two samples from the same patient upon comparison with repeat results from an alternate platform.Quality control was reviewed and was acceptable.Sample handling was reviewed with the customer.Samples are immediately frozen after draw and shipped frozen to the lab.The limitations section of the instructions for use (ifu) states the following: "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.[see boscato lm, stuart mc.Heterophilic antibodies: a problem for all immunoassays.Clin chem 1988:34: 27-33.] samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result.These reagents have been formulated to minimize the risk of interference; however, potential interactions between rare sera and test components can occur.For diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings." siemens is investigating.Mdr 1219913-2022-00095 and 1219913-2022-00097 were filed for the same event.

Event Description

The customer observed depressed immulite 2000 xpi calcitonin results from two samples from the same patient upon comparison with repeat results from an alternate platform.The discordant results were not reported to the physician(s).There were no reports that treatment was altered or postponed or adverse health consequences due to the discordant depressed immulite 2000 xpi calcitonin results.

Manufacturer Narrative

The initial mdr 1219913-2022-00095 was filed on april 5, 2022.Additional information - april 28, 2022.An outside the united states customer reported a low patient result with the immulite 2000 calcitonin kit lot 322 verses an alternate method.A result of 5.9 ng/l was observed on the immulite 2000 and a result of 213 ng/l on the alternate method.The customer retested the sample treated with a heterophilic blocking tube (hbt) and produced a result of 1.9 ng/l on the immulite 2000.Initial results between the immulite 2000 and the alternate method show a difference in clinical interpretation.Patient clinical history and diagnosis are "unclear" according to physician due to other diagnostic testing.The patient medication list contains various treatments for various symptoms.As part of the investigation, an additional sample from the patient was drawn from the patient and similar results were obtained: immulite2000: 2.3 ng/l , alternate method: 300 ng/l.The sample was retested with hbt on the alternate method and produced a result of < 1 ng/l.When using hbt, the alternate method and immulite 2000 calcitonin results are depressed, indicating heterophilic antibodies are interfering with results on both methods.Due to sample stability samples are unable to be tested in house.The customer stated that it is unclear whether the immulite 2000 results are correct or whether the alternate method results are correct.Siemens reviewed kit release data for lot 322 and it met all manufacturer specifications.The customer reports a valid adjustment and qc was in range during patient testing.When using hbt, the alternate method and immulite 2000 calcitonin results are depressed, indicating heterophilic antibodies are interfering with results on both methods.Considering patient medication list and the use of hbt showing possible heterophilic antibody interference, both could be contributing to the lower results.Heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.No systemic product issue is observed.The customer is operational.No further action is needed.In section h6, investigation findings, and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2022-00095 supplemental 1 and 1219913-2022-00097 supplemental 1 were filed for the same event.

• Brand Name: IMMULITE 2000 XPI CALCITONIN
• Type of Device: IMMULITE 2000 XPI CALCITONIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRIVATE LIMITED; gwynedd; glyn rhonwy, llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; walpole, MA 02032 ; 7372808688
• MDR Report Key: 14014476
• MDR Text Key: 289210932
• Report Number: 1219913-2022-00095
• Device Sequence Number: 1
• Product Code: JKR
• UDI-Device Identifier: 00630414961156
• UDI-Public: 00630414961156
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K023304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 10381446
• Device Catalogue Number: 10381446
• Device Lot Number: 322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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