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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's quality control (qc) was within acceptable range.Before immulite 2000 xpi human chorionic gonadotropin (hcg) sample testing, the customer will use hcg strip for preliminary screening, and then review the report.If the immulite 2000 xpi human chorionic gonadotropin (hcg) result is not consistent with the test strip result, the customer will repeat testing.The value of the result after repeat is evaluated.If it is consistent with the test strip result, then the result will be reported.Siemens provided service recommendations to the customer to help troubleshoot the hcg observed issue.The limitations section of the instructions for use states the following: "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.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 healthcare diagnostics continues to investigate.

Event Description

A customer tested a patient sample with immulite 2000 xpi human chorionic gonadotropin (hcg) multiple times on the same day on the same instrument.There was inconsistency between the replicates.The customer indicated that a corrected report was issued to the physician.It is unknown which of the repeat replicate results were provided to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant hcg results.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr 1219913-2021-00060 on 01/27/2021.Additional information - 2021-02-11.Troubleshooting was performed per recommendation and results are as follows: water test jan 25, 2021: sn (b)(6) : smp probe= 824, reagent probe= 823, water probe= 828, substrate only= 804(acceptable results).Precision study was performed using biorad qc lot 40380, n=5: level 1 mean= 9.94 cv= 4.86% level 3 mean= 199 cv=4.54%.Study was performed with non-pregnant female samples, n=5: sample 1 = <1, sample 2= 1.63, sample 3= <1.Siemens provided additional service recommendations followed by a verification run and has also requested instrument log files.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed mdr initial report on 01/27/2021 and mdr supplemental 1 report on 03/04/2021.Additional information - 05/10/2021 data from troubleshooting at the customer site was provided to siemens for review.The instrument watertest results are not within specification for this system.Additional troubleshooting recommendations were provided.Additional information - 05/13/2021 siemens has concluded investigation into discordant patient results when running the immulite 2000 xpi hcg assay.The limitations section of the instructions for use states the following: "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.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." this customer observed multiple non-reproducible discordant patient results when running the immulite 2000 xpi hcg assay with lots 455, 457 and 460.No issues were reported with immulite 2000 xpi hcg control performance.The discordant issue was seen on a subset of hcg samples tested on the system.The impacted samples were high and discordant when initially tested.The same sample tubes were repeated without re-centrifugation.The repeat immulite 2000 xpi hcg values were significantly lower and were considered accurate based on patient clinical status.Pre-analytics were investigated and sample handling recommendations were provided to the customer.Siemens reviewed instrument files but did not identify any sample or reagent level sense issue and no other instrument errors that would have caused the discordant results.Siemens local customer service engineer (cse) performed recommended service, which included decontaminating the system.Post service, immulite 2000 xpi hcg precision was verified and found to be acceptable using both bio-rad qc and non-pregnant female samples.Troubleshooting water test results were provided to siemens and showed results exceeding the specification.Siemens recommended another system decontamination and use of a different water source.Following this request, customer discontinued use of the immulite 2000 xpi hcg assay.No additional troubleshooting will be performed for this issue.A product problem has not been confirmed.In section h6, investigation finding, and investigation conclusion codes were updated based on the investigation results.

Manufacturer Narrative

Initial mdr 1219913-2021-00060 was filed on 2021-01-27, mdr 1219913-2021-00060 supplemental 1 report was filed on 2021-03-04 and mdr 1219913-2021-00060 supplemental 2 report was filed on 2021-05-27.Additional information - 2022-02-22.Siemens healthcare diagnostics further investigated the issue and confirmed the potential for falsely elevated 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.Section h9 was updated with the correction/removal (crr) report number 2432235-03/04/2022-002-c.In section h6, type of investigation, investigation finding, and investigation conclusion codes were updated based on additional information.

• 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; gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 5086605000
• MDR Report Key: 11238416
• MDR Text Key: 250849123
• Report Number: 1219913-2021-00060
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K990222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• Is the Device Single Use?: No
• 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