MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+

Catalog Number 10379675

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

Customer indicated that both patient samples had been discarded and were unavailable for return.Customer returned 1 bottle of lot 506706 strips to siemens for investigation.Siemens is in process of investigating customer returned strips.The root cause for the false positive urobilinogen results is unknown.

Event Description

Customer reported false positive urobilinogen results on two patient samples.There was no report of injury due to this event.

Manufacturer Narrative

Customer reported urobilinogen (uro) results by status+ method higher than by visual method for two (2) patient samples when using multistix 10sg lot 506076 (exp 2016-12).Specifically, it was reported that samples read as 2mg/dl visually were reported as 8mg/dl by status+ -- a 2 color block difference.One (1) partial bottle of multistix 10sg lot 506076 (total (b)(4) strips) were sent to (b)(4) technical operations for investigation.The submitted reagent strips showed no obvious visible damage or degradation.The bottle arrived tightly capped and containing the expected desiccant.Performance of supplied reagent was tested by both visual & status+ instrument methods using uro test solutions at 1mg/dl, 4mg/dl, & 8mg/dl concentration.Comparison of results from both methods showed 100% agreement at the 1mg/dl & 8mg/dl test levels.A the 4mg/dl level, 17% of visual results reported 1 color block lower and 67% of instrument results reported 1 color block higher.The customer observation of a 2 block color difference for samples tested both visually and by a status+ instrument with multistix 10sg lot 506076, as reported in gsms (b)(4), was observed; however, test results were found to meet expectation.All results were found to be within one color block of the assigned test solution value.The multistix 10sg product insert states that "results will usually be within one level of the true concentration.".

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5315663
• MDR Text Key: 34035313
• Report Number: 1217157-2015-00187
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1