MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM FOLATE; ACID, FOLIC, RADIOIMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

The customer observed an elevated atellica im folate result compared to repeat testing.The customer noted that quality control (qc) results were out of range.The customer changed the ancillary pack and the qc was in range.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.

Event Description

The customer observed an elevated atellica im folate result compared to repeat testing.The elevated result was reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated atellica im folate result.

Manufacturer Narrative

Mdr 1219913-2021-00321 was filed on (b)(6) 2021.July 28, 2021 - additional information: siemens investigated a customer observation of atellica im 1600 folate lot 309 of a discordant patient result and qc out-of-range and did not identify a potential product problem.Siemens reviewed the decrecord and found that one primary readypack id p07131314009467 is associated with the high out of range biorad controls 85231t and 85233t.The most likely cause of the high control recovery and discordant patient result is due to an isolated shipping, storage, or handling issue with the specific readypack id p07131314009467.No further complaints have been received.In addition, routine troubleshooting does not identify an issue in the customer's laboratory.No potential product issue was identified.Customer is operational.No further action is needed.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM FOLATE
• Type of Device: ACID, FOLIC, RADIOIMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11838661
• MDR Text Key: 251686913
• Report Number: 1219913-2021-00321
• Device Sequence Number: 1
• Product Code: CGN
• UDI-Device Identifier: 00630414598963
• UDI-Public: 00630414598963
• Combination Product (y/n): N
• PMA/PMN Number: K172201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995572
• Device Lot Number: 309
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1