MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE/IMMULITE 1000 TOXOPLASMA QUANT IGG; IMMULITE 1000 - TOXOPLASMA QUANTITATIVE IGG (TXP)

Model Number	IMMULITE 1000 - TOXOPLASMA QUANTITATIVE IGG (TXP)
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center.Siemens headquarters support center (hsc) is reviewing the data provided by the customer.The cause for the discordant false positive txp sample result is not yet known.Siemens is investigating the issue.Mdr 2432235-2019-00455 was filed for the same event.
Event or Problem Description
One discordant, false positive toxoplasma igg (txp) result was obtained using immulite 1000.The initial result was reported to the physician(s) and questioned.The sample was sent to another laboratory and was repeated using an alternate non-siemens method.The repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, false positive txp result.
Additional Manufacturer Narrative
The initial mdr 2432235-2019-00454 was filed on 16-dec-2019.Additional information (9-jan-2020): siemens headquarters support center (hsc) reviewed the information provided by the customer.Hsc found that the samples were sent to an alternate laboratory, tested on an alternate method for txp, and the results were found negative as expected by the customer.The samples were not repeated on the immulite 1000 and the customer did not treat the samples with heterophilic blocking tube (hbt) and /or with non-specific antibody blocking tubes (nabt).The adjustment and quality control (qc) were found acceptable by siemens regional support center (rsc).Hsc reviewed customer's predilution performance and the immulite 1000 operator's guide protocol was followed and sample handling was in accordance with the txp ifu recommendations.No additional sample is available for further evaluation.While there is insufficient information to determine the cause of the initial false positive txp results, hsc cannot rule out possible heterophilic antibodies.As stated in the immulite/immulite 1000 toxoplasma quantitative igg: "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." the customer was unable to provide the total number of negative samples tested with immulite 1000 txp lot 402; hsc cannot calculate the specificity for this account.The specificity results from the 3 studies in the immulite 1000 toxoplasma quantitative igg instructions for use (ifu) have 95% confidence limits ranging from 94.2% - 100%.A search of siemens complaint database on 2-jan-2020 found no other complaints with immulite 1000 txp lot 402.Based on the available information immulite 1000 toxoplasma igg lot 402 is performing as intended.No product problem was identified, and the customer is operational.The instrument is performing within specification.No further evaluation of the device is required.Sections h6 and h10 were updated to reflect the additional information received on 9-jan-2020 mdr 2432235-2019-00455-s1 was filed for the same event.

• Brand Name: IMMULITE/IMMULITE 1000 TOXOPLASMA QUANT IGG
• Common Device Name: IMMULITE 1000 - TOXOPLASMA QUANTITATIVE IGG (TXP)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9477335
• Report Number: 2432235-2019-00454
• Device Sequence Number: 14017798
• Product Code: LGD
• UDI-Device Identifier: 00630414964805
• UDI-Public: 00630414964805
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: IMMULITE 1000 - TOXOPLASMA QUANTITATIVE IGG (TXP)
• Device Catalogue Number: 10381268
• Device Lot Number: 402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR