MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC MICROFAST 5J

Catalog Number J1016-83

Device Problems Nonstandard Device (1420); Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/24/2012

Event Type  malfunction  

Event Description

A customer complaint was received for seven s.Agalactiae isolate with multiple antibiotic misreads.See mdrs 2919016-2014-00001 through 291906-2014-00007.Initial testing did not confirm the customer results but on retest the results were duplicated.It is unk if the patients were treated based on the discrepant results or if there was a delay in treatment.Siemens conducted the field correction, internal number msc 13-02, fda number z-1272-2013 on 03/06/2013, for false skipped wells and false susceptible misreads with s.Agalactiae affecting multiple antimicrobial agents on microscan microstrep plus type 1 panels (b1027-201), microstrep plus type 5 panels (b1016-95), microfast type 5j panels (j1016-83) and microfast type 7j panels (j1016-84).The customer letter stated results should be visually verified for s.Agalactiae isolates on the above panel types.A review of complaints associated with this field correction determined a mdr was needed.

Manufacturer Narrative

Method: use testing: the isolate was tested at microscan using microfast 7j panel.Results - incorrect data definition - discrepant results were not confirmed.Conclusion - design deficiency - the microscan testing did not confirm the misreads.

• Brand Name: MICROFAST 5J
• Type of Device: MICROFAST 5J
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 2040 enterprise blvd.; west sacramento CA 95691
• Manufacturer Contact: leslie ardizone ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9163743075
• MDR Report Key: 3704709
• MDR Text Key: 4331463
• Report Number: 2919016-2014-00001
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/14/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J1016-83
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1272-2013
• Patient Sequence Number: 1