MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG); IMMULITE 2000 HCG

Model Number N/A

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

The customer observed an elevated immulite 2000 xpi human chorionic gonadotropin (hcg) result for a patient sample compared to repeat testing of the same sample.The initial result was not reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated immulite 2000 xpi hcg result.

Manufacturer Narrative

An outside the united states customer observed an elevated immulite 2000 xpi human chorionic gonadotropin (hcg) result for a patient sample compared to repeat testing with the same sample.Siemens healthcare diagnostics is investigating this event.The limitations section of the instructions for use states the following: "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.".

Manufacturer Narrative

Mdr 1219913-2022-00044 was filed on january 26, 2022.Additional information - january 31, 2022.An outside the united states customer reports immulite 2000/xpi hcg non-reproducible patient results that are higher than expected.The customer informed siemens that sample tubes are centrifuged for at least 30 minutes.Siemens evaluated precision data provided by the customer and determed that acceptable precision was observed.This customer has not reported any concerns with immulite 2000/xpi hcg adjustment and/or quality control (qc) performance.The customer is repeating samples that result 6-80 iu/ml.Siemens is continuing to investigate.

Manufacturer Narrative

Initial mdr 1219913-2022-00044 was filed on january 26, 2022.Mdr 1219913-2022-00044 supplemental-1 was filed on february 24, 2022.Additional information - february 22, 2022 siemens healthcare diagnostics further investigated the issue and confirmed the potential for falsely elevated human chorionic gonadotropin (hcg) results due to sample carryover.This can be observed when a sample is assayed for hcg immediately after an undiluted sample with a hcg value of >5000 miu/ml.This issue impacts serum and urine patient samples, as well as quality control samples and adjustors.The effect of carryover varies based on the concentration of the high hcg sample.Starting 2022-02-22 an urgent medical device correction (umdc, letter imc22-04.A.Us) was sent to us customers, and an urgent field safety notice (ufsn, letter imc22-04.A.Ous) was sent to outside the us (ous).The umdc and ufsn explain the potential for carryover from high hcg samples into the next sample assayed for hcg on the immulite 2000/immulite 2000 xpi, and provides instructions to the customers.In section h6, type of investigation, investigation finding, and investigation conclusion codes were updated based on additional information.Section h7 was updated to reflect a recall and section h9 was updated to include the correction/ removal reporting number.

• Brand Name: IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG)
• Type of Device: IMMULITE 2000 HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 13357341
• MDR Text Key: 295507595
• Report Number: 1219913-2022-00044
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K990222
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 01/31/2022; 02/22/2022
• Supplement Dates FDA Received: 02/24/2022; 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2432235-03/04/2022-002-C
• Patient Sequence Number: 1