MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 5 100 STR.; URINE TEST STRIPS

Catalog Number 11893467119

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable results for one patient from chemstrip 5 ob test strips.The customer did a visual test on a the patient sample and the results for protein, blood, leukocyte, and glucose were all negative.The doctor did not believe the results based on the medical status of the patient and had the same urine sample tested on the chemstrip 10md strips with urisys 2400 and cobas analyzers in the laboratory.The results were protein: 500 mg/dl, blood: 250 ery/ul, leukocyte: 500 leu/ul, and glucose: 1000 mg/dl.The customer repeated the test on the chemstrip 5 ob test strips and received the same negative results.The customer repeated the test on the urisys 2400 and cobas analyzers with chemstrip 10md strips and the results all matched the previous results from these analyzers.The patient was not adversely affected.Controls passed for level 1 and level 2 on the chemstrip 5 ob test strips.The retention material of lot 12539900 was tested with native urine and a leukocyte-nitrite-protein-glucose and blood dilution series.No false negative result was observed.The reaction colors were in accordance with the standard label.

Manufacturer Narrative

One vial of strip lot 12539903 was received containing 103 test strips.As a strip vial is usually filled with 100 test strips, the 103 strips received suggest that there are strips from several vials and possibly different lots inside.This handling is not in accordance with the instructions for use.The customer material and retention material were tested visually with native urine and a nitrite, leukocyte, glucose, protein, and blood dilution series.The reaction colors were in accordance to the standard label and no false negative reactions were observed.No other complaints have been received for this lot of strips.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.No further information about sample preparation, storing conditions, or sample measurement was provided.The medications provided are not listed as potential interferences in product labeling for each parameter.

• Brand Name: CHEMSTRIP 5 100 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6328685
• MDR Text Key: 67536374
• Report Number: 1823260-2017-00306
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 11893467119
• Device Lot Number: 12539903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALBUTEROL; LEVOFLOXACIN; PREDNISONE; TYLENOL
• Patient Age: 56 YR
• Patient Weight: 77