MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379675

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.Proper maintenance and technique were reviewed with the customer and confirmed.Siemens requested the reagent to be returned for further investigation.The urine sample is no longer available.The cause of the event is unknown.

Event Description

The customer reported a false negative urine hcg result on the clinitek status+ when compared to a serum quantitative analysis on another siemens lab analyzer and a positive ultrasound.There was no report of injury due to this event.

Manufacturer Narrative

Updated contact office - name/address.Tech ops has completed the investigation: clinitest hcg reagent, patient urine sample and qc were received for investigation.The submitted reagent showed no obvious signs of damage or degradation; individual cassette foil packages properly sealed, containing the expected desiccant & micropipette.The urine sample, about 3-4ml in volume, was shipped cold (non-frozen) and had a clear yellow appearance with no notable haze/particulates.Submitted control solutions, also shipped cold, consisted of one (1) 5ml squeeze bottle of each l1 (negative) & l2 (positive).There were no false negative results observed.The submitted urine sample was also sent to the siemens chemistry and immunoassay group (los angeles, ca) for quantitative hcg determination by immulite analysis, a preferred instrument method for hcg confirmatory testing.This analysis reported the urine sample to contain 0.325miu/ml of hcg, a clinically negative result.Based on the data collected, the customer report of false negative hcg performance from clinitest hcg lot 065813 when tested on a clinitek status+ instrument, was not reproduced.The customer stated they have not had any further discrepancies and the instrument is operational.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8413926
• MDR Text Key: 139194109
• Report Number: 3002637618-2019-00028
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• Combination Product (y/n): N
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

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: 10379675
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1