MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS POSITIVE COMBO PANEL TYPE 33

Model Number B1017-211

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/27/2014

Event Type  malfunction  

Event Description

It was reported tha organism identification discrepancies were noted between microscan positive combo panel type 33 and microscan rapid positive id panel type 2 isolates taken from the same bap purity plate were identified as high probability kocuria kristinae (96.55%) and low probability staphylococcus lugdunensis (1.52%) on microscan positive combo panel type 33 ((b)(4)) on both initial and repeat test.Another method was set up using microscan rapid positive id panel type 2 ((b)(4)) resulting in high probability staphylococcus lugdunensis (99.99%) on both initial and repeat tests.The isolate was submitted to a reference laboratory for identification testing and resulted as high probability of staphylococcus lugdunensis.It is unknown what testing method was used by the reference laboratory to attain the organism id.The customer reported that the identification was previously finalized s coagulase negative staphylococcus species.Upon receipt of the results from the reference laboratory, the final identification was changed to staphylococcus lugdunensis and reported to the physician.There was no report of adverse event or injury associated with the discrepant results.

Manufacturer Narrative

(b)(4): method - the customer sent the isolate to the reference lab for identification testing.Result - for use when no methods were performed and therefore no results will be obtained.The customer sent the isolate to the reference laboratory for identification testing and staphylococcus lugdunensis was obtained.

• Brand Name: POSITIVE COMBO PANEL TYPE 33
• Type of Device: POSITIVE COMBO PANEL TYPE 33
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; west sacramento CA
• Manufacturer Contact: jose untalan ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9163743031
• MDR Report Key: 4385009
• MDR Text Key: 5120869
• Report Number: 2919016-2014-00046
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2015
• Device Model Number: B1017-211
• Device Catalogue Number: B1017-211
• Device Lot Number: 2015-07-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1