MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 FREE PSA

Model Number IMMULITE 2000 FREE PSA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Assay adjustment (calibration) and quality control data from the customer has been provided for investigation.The cause of the discordant, falsely elevated results with the immulite 2000 free psa assay is unknown.Siemens is investigating the issue.Mdr 2432235-2019-0036 was filed for the same issue.

Event Description

Discordant, falsely elevated results were obtained with two reagent lots of the immulite 2000 free psa assay on an immulite 2000 xpi instrument.The discordant results were reported to the physician(s) and were questioned.The same samples were repeated on an alternate platform from roche diagnostics.The results from the alternate platform were lower and considered to be correct.Corrected reports were issued to the physician(s) with the results from the roche diagnostics device.There are no known reports of any impact to patient treatment or intervention due to the discordant, falsely elevated free psa results.There are no known reports of a delay in administering treatment or medical intervention to the patients due to the discordant, falsely elevated free psa results.

Manufacturer Narrative

The initial mdr 2432235-2019-00035 was filed on 11-jan-2019.Supplemental mdr 2432235-2019-00035_s1 was filed on 11-feb-2019.Additional information (01-mar-2019): the three patient samples from the customer were evaluated by the siemens technical support laboratory (tsl).All three samples were treated using a heterophilic blocking tube (hbt) and tested on the immulite 2000 xpi free psa assay - kit lot 312.All calibrations/ adjustments and quality control material recoveries were within acceptable limits.Sid: (b)(6) - ear produced a very low free psa result, post hbt treatment, when compared to the free psa result on the untreated sample, indicating that heterophilic antibodies may have caused the initial falsely elevated result.Sid: (b)(6) - jss produced a lower free psa result, post hbt treatment when compared to the free psa result of the untreated sample.However the treated free psa result was higher than that on an alternate platform.Sid: (b)(6) - mas produced similar free psa result post hbt treatment when compared to the free psa result of the untreated sample and were similar to the results obtained by the customer.Additional information (11-mar-2019): a siemens headquarter support center specialist (hsc) reviewed the calibration/ adjustment data with immulite 2000 xpi free psa lots 310 and 311 from the customer.The hsc specialist noted that between (b)(6) 2018 to (b)(6) 2018, the customer struggled with the calibration/ adjustment of immulite 2000 xpi free psa kit lot 310 and the mean counts per second were higher than the release data.The calibration/ adjustment with immulite 2000 free psa kit lot 311 was comparable with the release data.Quality control material recoveries were within ranges and comparable with peer data.The customer obtained discordant results with two different kit lots of immulite 2000 free psa assay, indicating that the issue is not specific to a particular kit lot.There have been no additional reports of discordant results with immulite 2000 xpi free psa assay - lot 310 and lot 311.The above testing results do not indicate a product performance issue with the immulite 2000 xpi free psa assay, but the possibility of interference from heterophilic and/ or non-specific binding antibodies or sample specific issues.Immulite 2000 xpi free psa kit lots 310 and 311 are performing according to specifications.No further evaluation of the device is required.The method, result and conclusion codes have been updated in evaluation codes mdr 2432235-2019-00036_s2, mdr 2432235-2019-00053_s1 and mdr 2432235-2019-00054_s1 were filed for the same issue.

Manufacturer Narrative

The initial mdr was filed on 11-jan-2019.Additional information (18-jan-2019): a siemens customer care center (ccc) specialist stated that the date of event for one of the samples (sid (b)(6) - ear) was (b)(6) 2018 and not (b)(6) 2018.Mdr 2432235-2019-00053 and mdr 2432235-2019-00054 were filed for this new event date.The ccc specialist stated that the patients were not taking any medication or supplement.Arrangements are being made to send the samples to siemens for investigation.Mdr 2432235-2019-00036_s1 was filed for the same issue.

• Brand Name: IMMULITE 2000 FREE PSA
• Type of Device: IMMULITE 2000 FREE PSA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• MDR Report Key: 8240519
• MDR Text Key: 133548715
• Report Number: 2432235-2019-00035
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P060005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: IMMULITE 2000 FREE PSA
• Device Catalogue Number: L2KPF2
• Device Lot Number: 310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/18/2019; 03/01/2019
• Supplement Dates FDA Received: 02/11/2019; 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1