MAUDE Adverse Event Report: BECKMAN COULTER, INC. MICROSCAN LABPRO; MEDICAL DEVICE DATA SYSTEM

Model Number 4.11PU5

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

Patient Problem No Information (3190)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

Review of the submitted data revealed specimen numbers stored in (b)(4), m145f and m145g, was likely downloaded from the (b)(4).The "f" tag was applied to 2015 and "g" to 2016.Both specimens had collect dates that corresponded to download and run dates.Device configuration indicated the active specimen date range was set to 180 days.Microbiology reports for each specimen indicate the correct ast results were stored in (b)(4) for each specimen.The customer further reported that they manually transmit all specimens and use the "active specimens only" and "test group status date = 0" settings.Customer stated they did not visually confirm the results before transmitting.Customer stated that both specimens were downloaded from the (b)(4) so each should have had a tag applied for the year, making them unique.The failure mode for the incorrect susceptibility reporting was likely user error.Since the customer reuses specimen numbers, it is likely that the previous year specimen was inadvertently selected by the user during manual transmission of the results.There is insufficient evidence to suggest an instrument, software, or panel malfunction.Data provided confirmed the correct results were stored in (b)(4) for each specimen and the software functioned as intended; results reported by (b)(4) were based on customer input.(b)(4).

Event Description

The customer reported that incorrect susceptibility results were reported out of the lab for an escherichia coli isolate with multi-drug resistance.The customer stated they reuse specimen numbers and discovered that the (b)(4) report for a recent specimen tested in (b)(6) was reported incorrectly.The isolate was an esbl positive e.Coli from a urine source with multiple drug resistance; the drugs were reported out as susceptible.Customer reported it appeared that the ((b)(6) hospital system) had results from the same specimen number tested in 2015 - same panel type, same id, but esbl negative.The customer stated the patient was treated with ciprofloxacin however when the corrected report was released, the patient was put on a different drug, details unknown.Customer stated the results were finalized on (b)(6) 2016 and the corrected report was issued on (b)(6) 2016.Patient treatment was impacted in connection with this event.

• Brand Name: MICROSCAN LABPRO
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: elizabeth church ; 1584 enterprise blvd.; west sacramento, CA 95691 ; 9163742457
• MDR Report Key: 5478588
• MDR Text Key: 39629238
• Report Number: 2919016-2016-00003
• Device Sequence Number: 1
• Product Code: OUG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: 4.11PU5
• Device Catalogue Number: 10806419
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other