MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEST HCG PREGNANCY TEST

Lot Number 053119

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens customer care center (ccc) team found out that test table carriage was being cleaned quarterly and test table insert was cleaned intermittently between tests.Ccc advised customer to check test table daily and clean weekly.Customer cleaned test table and test table insert under distilled water prior to calling in; no further issues have been observed.Siemens is in process of evaluating customer returned cassettes to check if there's any other issue associated with analyzer or assay.

Event Description

Customer reported false negative hcg result on the analyzer when compared to positive hcg result from serum quantitative test.There was no report of injury due to this event.

Manufacturer Narrative

Reagent was returned for investigation.Siemens technical operator was unable to reproduce the reported event.Proper technique and maintenance were reviewed with the customer.Numerous factors can contribute to a discrepant hcg result, including the instrument, reagent cassettes, and operators.The cause of the discrepancy in results cannot be determined based up on the information that customer provided.Customer has had no further issues.A review of complaint does not show any indication that there is a systemic product nonconformance with this lot.

• Brand Name: CLINITEST HCG PREGNANCY TEST
• Type of Device: CLINITEST HCG PREGNANCY TEST
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 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: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5803985
• MDR Text Key: 49953078
• Report Number: 1217157-2016-00075
• Device Sequence Number: 1
• Product Code: JHI
• 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: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 053119
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1