MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. POSITIVE COMBO 33; GRAM POSITIVE PANEL TYPE 3

Model Number B1017-211

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Not Applicable (3189)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

The customer received unacceptable response for s.Aureus oxacillin mic interpretation on the college of american pathologist (cap) bacteriology survey isolate d-05, 2014.S.Aureus oxacillin result of 0.5 mcg/ml was interpreted as susceptible.Per the cap participant summary report, s.Aureus oxacillin mic is resistant at 99.8% consensus.There was no patient involved.The discrepancy was observed in cap proficiency survey.

Manufacturer Narrative

The customer performed 6 repeat panel testing using new pc 33 panel lot 2015-01-23 on the same day and the remaining single panel from the original lot 2014-12-04 was tested on a different day.All 7 panel results revealed that the oxacillin mics were all in agreement with a mic of >2 mcg/ml and interpreted as resistant.Review of the instrument maintenance and environmental conditions showed all values are acceptable and within range.The customer agrees that cap ox mic failure is not attributed to the panel or instrument issue, since all subsequent testing with original panel lot # 2014-12-04 and second panel lot number lot # 2015-01-23 yielded correct response for oxacillin interpretation.There was no patient involved.The discrepancy was observed in cap proficiency survey.

• Brand Name: POSITIVE COMBO 33
• Type of Device: GRAM POSITIVE PANEL TYPE 3
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; west sacramento CA
• Manufacturer Contact: jose untalan ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9143743031
• MDR Report Key: 4073515
• MDR Text Key: 4742531
• Report Number: 2919016-2014-00025
• 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
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1017-211
• Device Catalogue Number: B1017-211
• Device Lot Number: 2014-12-04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1