MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS; CT ADVANTUS

Catalog Number 10329726

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  No Answer Provided  

Event Description

Customer reported 2 false negative results on the instrument whereas microscopic results were positive for both patients.There was no report of injury due to this event.

Manufacturer Narrative

Patient was taking keflex (cephalexin).As per multistix reagent strips instruction for use, under section leukocytes limitations, "the presence of cephalexin (keflex), cephalothin (keflin), or high concentrations of oxalic acid may also cause decreased test results." patient sample had high glucose content of >=3 g/dl.As per multistix reagent strips instruction for use, under section leukocytes limitations, "elevated glucose concentrations (>=3 g/dl) may cause decreased test results." customer has been provided with document 26181 "reprint of technitips report number t93-01 (august 1993): causes of leukocyte discrepancies between reagent strip and microscopic method".Both patients had sg >1.030, which is known to cause falsely lowered leukocyte esterase results on multistix reagent strips.Instrument and multistix strip are performing as intended.

Manufacturer Narrative

Corrected data: other relevant history, including preexisting medical conditions: patient was not on antibiotics like keflex and tetracycline.Both patients had sg >1.030, which is known to cause falsely lowered leukocyte esterase results on multistix reagent strips.Customer has been provided with (b)(4).Instrument and multistix strip are performing as intended.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CT ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): KIMBALL ELECRONICS; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne, 6208 0; PL 62080
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4287778
• MDR Text Key: 21171328
• Report Number: 1217157-2014-00171
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063276
• 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: 11/06/2014

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: Other
• Device Catalogue Number: 10329726
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2015
• Is the Device Single Use?: No
• Patient Sequence Number: 1