COBAS PCR URINE SAMPLE KIT
Received Mar 27, 2013 · Event occurred Mar 1, 2013
Report 2243471-2013-00005 · MDR key 3023983
Device
Generic name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Manufacturer
Roche Molecular SystemsCatalog number
05170486190
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
ON (B)(6) 2013, A DOCTOR FROM (B)(6) HOSPITAL, (B)(6) CALLED ROCHE TO REPORT THAT A YOUNG CHILD HAD BEEN ADMITTED TO THE HOSPITAL AFTER INGESTING PCR MEDIA FORM THE URINE COLLECTION TUBE CONTAINED IN THE COBAS PCR URINE SAMPLE KIT (M/N 05170486190). ALTHOUGH REPEATED FOLLOW UP ATTEMPTS WERE MADE TO CONTACT THE DOCTOR TO OBTAIN FURTHER INFORMATION REGARDING THE INCIDENT AND CONDITION OF THE CHILD, NO ADDITIONAL INFORMATION IS AVAILABLE. IT IS UNKNOWN HOW THE CHILD CAME INTO CONTACT WITH AND INGESTED THE PCR MEDIA.
Additional Manufacturer Narrative
RESULT - CHILD INGESTED LIQUID MEDIA FROM A REAGENT KIT. CONCLUSION - CHILD INGESTED LIQUID MEDIA FROM A REAGENT KIT. ALTHOUGH REPEATED FOLLOW UP ATTEMPTS WERE MADE TO CONTACT THE DOCTOR TO OBTAIN FURTHER INFORMATION REGARDING THE INCIDENT AND CONDITION OF THE CHILD, NO ADDITIONAL INFORMATION IS AVAILABLE. THE COBAS PCR URINE SAMPLE KIT PACKAGE INSERT STATES THE FOLLOWING IN THE WARNINGS AND PRECAUTIONS SECTION: AVOID CONTACT OF THE COBAS PCR MEDIA WITH THE SKIN, EYES OR MUCOUS MEMBRANES. IF CONTACT DOES OCCUR, IMMEDIATELY WASH WITH LARGE AMOUNTS OF WATER. COBAS PCR MEDIA 1 X 4.3 ML CONTAINS: < = 40% (W/W) GUANIDINE HYDROCHLORIDE, TRIS-HCL BUFFER, XN 25- 50% (W/W) GUANIDINE HCL. R: 22-36/38 HARMFUL IF SWALLOWED. IRRITATING TO EYES AND SKIN. S: 13-26-36-46 KEEP AWAY FROM FOOD, DRINK AND ANIMAL FEEDING STUFFS. IN CASE OF CONTACT WITH EYES, RINSE IMMEDIATELY WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE. WEAR SUITABLE PROTECTIVE CLOTHING. IF SWALLOWED, SEEK MEDICAL ADVICE IMMEDIATELY AND SHOW THIS CONTAINER OR LABEL. THE MATERIAL SAFETY DATA SHEET (MSDS) FOR COBAS PCR URINE SAMPLE KIT IDENTIFIES THE FOLLOWING HAZARDS AND FIRST AID MEASURES FOR INGESTION: INGESTION: HARMFUL IF SWALLOWED. INGESTION MAY CAUSE GASTROINTESTINAL IRRITATION, NAUSEA, VOMITING AND DIARRHEA. MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: NONE KNOWN. FIRST AID MEASURES FOR INGESTION: CONSULT A PHYSICIAN. DO NOT INDUCE VOMITING WITHOUT MEDICAL ADVICE. (B)(4).