MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number 10379680

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2023

Event Type  malfunction  

Event Description

The customer performed a urine strip test on their clinitek status+ using uro-hema-combistix.The urine strip was misidentified as labstix sg and the analyzer produced a result on the patient sample.Inspection of the strip, found that the id band, which the instrument uses to identify strip type, was missing.A new strip was used and the correct strip type was identified by the instrument and correct results reported.There is no report of injury due to this event.

Manufacturer Narrative

Investigation is underway.The cause of this event is unknown.

Manufacturer Narrative

Manufacturer has completed the investigaiton: retain samples and design history records from production processes (lamination and slit/fill/cap) were checked.All in process checks were performed and were positive.Retain samples review was positive, no issues were observed.The in-process control (100% card control) was not able to detect one card without a small fragment of component missing (ca.1,6 inch).A quality alert ((b)(6)) as well as retraining of operators from card control instruction ((b)(4) were provided to increase operators' awareness of the problem.The percentage of rip-off during production is low and fits within prearranged supplier ¿ customer agreement.No systemic product problem.Root cause is unknown.

• Brand Name: CLINITEK STATUS+
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 16820048
• MDR Text Key: 314085491
• Report Number: 3002637618-2023-00024
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10379680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1