MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TEST,HCG,PREGNANCY,COMBO,CASS,20/10 MIU

Model Number MPH22025HCG

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a (b)(6) year old patient was scheduled for an upper endoscopy and prior to the procedure the nurse performed a pregnancy test on the patient.The nurse reported that the patient's last reported menses was 11/2020 and the pregnancy test results on (b)(6) 2021 showed negative.The nurse disposed of the pregnancy test after the negative result was obtained and the upper endoscopy was performed.The patient was administered propofol during the procedure to put her to sleep and no procedural complications were noted.After the procedure the patient was discharged home and the gi clinic received a call from the patient stating her primary care physician called her and told her that she is 4 months pregnant.The patient's physician was notified that propofol was used during the procedure.There have been no adverse consequences reported related to the reported event.The facility tested 2 additional tests from the same lot with the controls that are provided for the product and both of the pregnancy tests were accurate.No additional information is available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that an inaccurate hcg pregnancy test result was obtained prior to a surgical procedure being performed and anesthesia being administered.

• Brand Name: MEDLINE
• Type of Device: TEST,HCG,PREGNANCY,COMBO,CASS,20/10 MIU
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11695275
• MDR Text Key: 246319779
• Report Number: 1417592-2021-00082
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10884389191880
• UDI-Public: 10884389191880
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPH22025HCG
• Device Catalogue Number: MPH22025HCG
• Device Lot Number: HCG0102005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 68