MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM BR 27.29 (BR); BR (27.29) IMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) and informed that a patient correlation study, quality control (qc), and calibration evaluation were performed to evaluate the high bias in patient samples for the br 27.29 assay.Siemens dispatched a customer service engineer (cse) to the customer site.The cse inspected the atellica im 1600 analyzer and performed qc and pack calibrations that yielded valid calibrations but noted that mean values were much higher than concentration.A calibration was performed on fresh packs with fresh calibrator material, and the cse noted that the mean was lower but still higher than concentration.Siemens is investigating the issue.

Event Description

The customer observed high cancer antigen (br 27.29) patient results and a high bias in quality controls (qc) on the atellica im 1600 analyzer with serial number (b)(4).The customer informed siemens that high br 27.29 results were reported and questioned by the physician(s).The customer used the same patient samples to perform repeat testing on an alternate atellica im 1600 analyzer (serial number (b)(4)) at the same customer site.The customer alleges that repeat test results matched the patient's clinical picture.However, the customer did not issue corrected reports and informed siemens that the analyzer ((b)(4)) is down for service.The event has caused a delay in testing and patient samples were sent to an alternate site for br 27.29 testing.There are no reports of patient intervention or adverse health consequences due to the high br 27.29 patient results.

Manufacturer Narrative

Siemens has investigated and confirmed atellica im br 27.29 (br) assay no longer meets the instructions for use (ifu) claimed pack calibration interval.Siemens distributed urgent medical device correction aimc 21-12.A.Us and urgent field safety notice aimc 21-12.A.Ous in (b)(6) 2021 to customers who have received the atellica im br assay.The communications inform customers of the assay not meeting the pack calibration interval and advises customers to change the pack calibration interval from 10 days to 3 days on each atellica im analyzer generating br results.An appropriate term/code for investigations findings was not available.The investigation findings indicate an issue with device stability.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2021-00044 on 16-feb-2021.Siemens filed the first supplemental mdr 2432235-2021-00044_s1 on 17-aug-2021.Correction (22-sep-2021): siemens made corrections to sections d1, d2, d4, g1, g4 and included the correct product information, manufacturing site, and premarket identification for the reported event.

• Brand Name: ATELLICA IM BR 27.29 (BR)
• Type of Device: BR (27.29) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 11334331
• MDR Text Key: 250025551
• Report Number: 2432235-2021-00044
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414002026
• UDI-Public: 00630414002026
• Combination Product (y/n): N
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995477
• Device Lot Number: 253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1219913-06-29-2021-003-C
• Patient Sequence Number: 1