MAUDE Adverse Event Report: IRIS INTERNATIONAL INSTRUMENT GENERATED TWO DIFFERENT CHEMISTRY SYSTEM FLAG MESSAGES (CHEMTRANSLATE; AUTOMATED URINALYSIS SYSTEM,

Catalog Number 700-7176-001

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

The customer indicated that the patient was prescribed antibiotic for asymptomatic pyuria as a result of the false positive result.The field service engineer (fse) was at the customer site and found the pipette alignment on the 2.5 ichem velocity was too low and not centered on the test strip.The fse also observed the pipette was touching the pads when dosing.He noted that the instrument was experiencing intermittent strip errors which he suspects may have been caused due to pipette alignment issue.The fse performed a pipette alignment resolving the issue and qc passed.All repairs were verified as per service procedures.Although the identified malfunction is not deemed reportable this event will be reported as an adverse event for the prescribed antibiotics.Bec internal identifier (b)(4).

Event Description

The customer reported while running patient samples on their 2.5 ichem velocity instrument, a sample recovered a high, false positive leukocyte on one patient (result: 108).The result was reported out of the lab and later on corrected by the lab technician.The customer indicated that the patient was prescribed antibiotic for asymptomatic pyuria as a result of the false positive result and then discharged.Additional information was requested regarding the patient impact but not provided, it could not be confirmed if the patient actually took the prescribed antibiotic.Instrument generated two different chemistry system flag messages (chemtranslate and chem confirm).The messages let the customer know that they need to confirm the result validity.

• Brand Name: INSTRUMENT GENERATED TWO DIFFERENT CHEMISTRY SYSTEM FLAG MESSAGES (CHEMTRANSLATE
• Type of Device: AUTOMATED URINALYSIS SYSTEM,
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: laurie o'riordan ; 9172 eton ave; chatsworth, CA 91311 ; 3053802874
• MDR Report Key: 7077115
• MDR Text Key: 93552647
• Report Number: 2023446-2017-00010
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001737
• UDI-Public: (01)10837461001737(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101852
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 700-7176-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 12/01/2017
• Date Device Manufactured: 03/06/2014
• 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
• Patient Age: 79 YR