COBAS PCR FEMALE SWAB KIT
Received Dec 19, 2017 · Event occurred Dec 5, 2017
Report 2243471-2017-00025 · MDR key 7128094
Device
Generic name
Dna Probe, Nucleic Acid Amplification, Chlamydia,
Manufacturer
Stacie-ann CreightonModel number
NACatalog number
05170516190
Lot number
NI
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Vomiting
- Toxicity
- Vomiting
- Toxicity
Narrative
Additional Manufacturer Narrative
THE INSTRUCTIONS FOR USE FOR COBAS PCR FEMALE SWAB KIT PROVIDES THE CONTENTS OF THE COBAS PCR MEDIA (= 40% (W/W) GUANIDINE HYDROCHLORIDE; TRIS-HCL BUFFER) AND INDICATES THAT THE MEDIA IS HARMFUL IF SWALLOWED AND ADVISES THAT IF SWALLOWED TO CALL A POISON CENTER OR DOCTOR/ PHYSICIAN IF FEELING UNWELL. THE SAFETY DATA SHEET FOR THE COBAS PCR MEDIA PROVIDES THE SAME INSTRUCTIONS AS THE INSTRUCTIONS FOR USE, AS WELL AS INDICATES TO RINSE MOUTH WITH WATER IF SWALLOWED AND DRINK PLENTY OF WATER AFTERWARDS. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION REGARDING THE CHILD'S STATE OF HEALTH OR TREATMENT INFORMATION WILL BE PROVIDED. (B)(4).
Description of Event or Problem
A CUSTOMER IN THE UNITED STATES REPORTED THAT A CHILD INGESTED COBAS PCR MEDIA (PACKAGED WITHIN THE COBAS PCR FEMALE SWAB KIT) AT THEIR FACILITY. IT WAS REPORTED THAT THE CHILD WAS VOMITING AS A RESULT OF INGESTING THE COBAS PCR MEDIA. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED REGARDING THE STATE OF THE HEALTH OF THE CHILD OR WHETHER TREATMENT WAS PROVIDED. THE CUSTOMER INDICATED THEY ADVISED THAT THE CHILD'S PARENT CALL POISON CONTROL.