MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. VERSANT KPCR MOLECULAR SYSTEM SP; CLINICAL SAMPLE CONCENTRATOR

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The versant kpcr molecular system sp is a sample extractor for nucleic-acid assays.While processing samples, a patient sample id was read by the versant kpcr molecular system sp from a barcoded label applied to a sample tube.In the assay result report, the indicated sample id (as read into the system by the barcode reader) differed by one digit from the number originally indicated on the label.As the incorrectly-assigned id did not match any patient records in the customer's system, the result in question was not transferred automatically to the customer lis.The id in the report was obviously incorrect to the reviewer upon review of the results.There was no patient harm or diagnostic delay associated with the observed issue.Local investigation showed that the customer's practice of spraying labeled samples tubes and wiping down with disinfectant visibly damages the barcoded labels, potentially interfering with the system's ability to read them.No malfunction of the instrument's barcode reader or software was identified.The observed error is the result of customer mishandling of labeled tubes.No further evaluation of the product is required.
Event or Problem Description
The customer observed assignment of an invalid patient id to a result record when using the versant kpcr molecular system sp, due to an apparent barcode-reading error.The incorrect id was apparent to the user, and did not lead to any loss or misdirection of result data.The error was corrected without consequence.There are no reports of patient intervention or adverse health consequences due to the observed error.

• Brand Name: VERSANT KPCR MOLECULAR SYSTEM SP
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11345886
• Report Number: 1219913-2021-00145
• Device Sequence Number: 19153470
• Product Code: JJH
• UDI-Device Identifier: 00630414541457
• UDI-Public: 00630414541457
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10282928
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1