ALERE ORATECT
Report
- Report Number
- 2032598-2018-00001
- Event Type
- Injury
- Date Received
- October 2, 2018
- Date of Event
- September 7, 2018
- Report Date
- September 7, 2018
- Manufacturer
- AMEDITECH, INC.
- Product Code
- DJC
- PMA / PMN Number
- K103227
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
THIS EVENT OCCURRED IN THE UNITED KINGDOM WITH A PRODUCT OF IDENTICAL MANUFACTURING TO A US MARKETED PRODUCT. AMEDITECH MADE THE DECISION TO REPORT THIS EVENT TO THE AGENCY BASED ON THE SIMILARITY BETWEEN THE PRODUCT INVOLVED IN THIS EVENT AND THE ORATECT III, CATALOG NUMBER HM12, PRODUCT MARKETED FOR IN VITRO DIAGNOSTIC USE IN THE UNITED STATES. DEVICE SIMILARITIES INCLUDE THE DETECTION ANALYTES USED TO OBTAIN TEST RESULTS, AND IDENTICAL SAMPLE COLLECTION PADS, WITH THE MAJOR DIFFERENCE BEING THE CE MARKED LABELING FOR THE DEVICES SOLD IN THE UNITED KINGDOM. THE SAMPLE COLLECTION PAD IS THE POINT OF CONTACT BETWEEN THE DEVICE AND THE PATIENT, AND IS THE LIKELY COMPONENT TO WHICH THE PATIENT MAY HAVE EXPERIENCED ALLERGIC SYMPTOMS. KLIGMAN MAXIMIZATION TESTING WAS PERFORMED ON THIS COLLECTION PAD IN 2014. THIS TESTING CATEGORIZED THE COLLECTION PAD WITH A GRADE 1 SENSITIZATION RATE, THE LOWEST AVAILABLE ALLERGIC POTENTIAL SCORE. THUS THE RISK OF ALLERGIC REACTION HAS BEEN REDUCED AS FAR AS POSSIBLE. A HISTORICAL REVIEW WAS CONDUCTED AND DETERMINED THAT THIS IS THE FIRST ALLERGIC REACTION REPORTED FOR THE CATALOG NUMBER, AND THE SECOND REPORT FOR THE ORATECT PRODUCT FAMILY SINCE DISTRIBUTION OF THE PRODUCT BEGAN IN 2012, THEREBY INDICATING A LOW FREQUENCY OF OCCURRENCE. THE SPECIFIC LOT IN QUESTION COULD NOT BE DETERMINED AS THE CUSTOMER DISCARDED THE DEVICE PRIOR TO REPORTING THE EVENT. HOWEVER, A REPORT OF HISTORICAL DISTRIBUTION TO THE CUSTOMER WAS GENERATED. THIS REPORT IDENTIFIED FOUR POSSIBLE SUSPECT LOTS AS RECEIVED BY THE CUSTOMER SINCE JANUARY 2017. MANUFACTURING RECORDS FOR LOTS 180744, 181687, 183430, AND 183454 WERE REVIEWED AND NO ABNORMALITIES WERE NOTED. RETENTION DEVICES FOR EACH OF THESE LOTS WERE THOROUGHLY INSPECTED FOR ANY PHYSICAL ABNORMALITIES; NONE WERE NOTED. RETENTION DEVICES FROM EACH OF THESE LOTS WERE THEN ALSO TESTED WITH MULTIPLE VOLUNTEER TEST SUBJECTS. THE TEST SUBJECTS DID NOT REPORT ANY TINGLING, BURNING, PAIN, SWELLING, OR OTHER SYMPTOMS THAT MIGHT INDICATE A POSSIBLE ALLERGIC REACTION. BASED ON THE INVESTIGATION DATA, NO ABNORMAL BIOLOGICAL RESPONSE WAS NOTED WITH THE USE OF THIS DEVICE. THE RISK ASSOCIATED WITH A MILD, SELF-LIMITED ALLERGIC REACTION WAS ASSESSED IN A HEALTH HAZARD EVALUATION FOR A PREVIOUS SIMILAR ALLERGIC REACTION. THIS ASSESSMENT INCLUDED EVALUATION BY A MEDICAL ADVISOR. DUE TO THE LIMITED TRANSIENT NATURE OF THE HEALTH CONSEQUENCES AND THE LOW FREQUENCY OF OCCURRENCE THE RISK OF ADVERSE HEALTH CONSEQUENCES WAS DETERMINED TO BE NEGLIGIBLE. AS SUCH NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.
ON (B)(6) 2018 A TEST SAMPLE FOR DRUG SCREENING ON AN ORATECT III DEVICE, CATALOG NUMBER HM12-CE WAS COLLECTED FROM A PATIENT. AFTER PROVIDING THE SAMPLE THE DONOR INFORMED THE TESTING TECHNICIAN THAT HE WAS EXPERIENCING SOME IRRITATION AND BLISTERING ON THE INSIDE OF HIS CHEEK, INDICATING A POSSIBLE ALLERGIC REACTION TO THE ORATECT DEVICE. THE PATIENT WAS MONITORED FOR SEVERAL MINUTES AND THE TESTING STAFF NOTED THAT NO FURTHER SYMPTOMS OCCURRED. THE PATIENT WAS THEN RELEASED, AND DID NOT SEEK FURTHER MEDICAL ATTENTION. REPEATED ATTEMPTS TO GATHER LOT NUMBER INFORMATION FROM THE CUSTOMER WERE MADE ON SEPTEMBER 7TH, 11TH, 12TH, 13TH, 19TH, 20TH, AND 24TH, HOWEVER THE CUSTOMER WAS UNABLE TO CONFIRM THE LOT OF PRODUCT INVOLVED IN THE EVENT.
THIS EVENT OCCURRED IN (B)(6) WITH A PRODUCT OF IDENTICAL MANUFACTURING TO A US MARKETED PRODUCT. AMEDITECH MADE THE DECISION TO REPORT THIS EVENT TO THE AGENCY BASED ON THE SIMILARITY BETWEEN THE PRODUCT INVOLVED IN THIS EVENT AND THE ORATECT III, CATALOG NUMEBR HM12, PRODUCT MARKETED FOR IN VITRO DIAGNOSTIC USE IN THE UNITED STATES. DEVICE SIMILARITIES INCLUDE THE DETECTION ANALYTES USED TO OBTAIN TEST RESULTS, AND IDENTICAL SAMPLE COLLECTION PADS, WITH THE MAJOR DIFERENCE BEING THE CE MARKED LABELING FOR THE DEVICES SOLD IN (B)(6). THE SAMPLE COLLECTION PAD IS THE POINT OF CONTACT BETWEEN THE DEVICE AND THE PATIENT, AND IS THE LIKELY COMPONENT TO WHICH THE PATIENT MAY HAVE EXPERIENCED ALLERGIC SYMPTOMS. KLIGMAN MAXIMIZATION TESTING WAS PERFORMED ON THIS COLLECTION PAD IN 2014. THIS TESTING CATEGORIZED THE COLLECTION PAD WITH A GRADE 1 SENSITIZATION RATE, THE LOWEST AVAILABLE ALLERGIC POTENTIAL SCORE. THUS THE RISK OF ALLERGIC REACTION HAS BEEN REDUCED AS FAR AS POSSIBLE. A HISTORICAL REVIEW WAS CONDUCTED AND DETERMINED THAT THIS IS THE FIRST ALLERGIC REACTION REPORTED FOR THE CATALOG NUMBER, AND THE SECOND REPORT FOR THE ORATECT PRODUCT FAMILY SINCE DISTRIBUTION OF THE PRODUCT BEGAN IN 2012, THEREBY INDICATING A LOW FREQUENCY OF OCCURRENCE. FURTHER INVESTIGATION IS ONGOING.
ON (B)(6) 2018 A TEST SAMPLE FOR DRUG SCREENING ON AN ORATECT III DEVICE, CATALOG NUMBER HM12-CE WAS COLLECTED FROM A PATIENT. AFTER PROVIDING THE SAMPLE THE DONOR INFORMED THE TESTING TECHNICIAN THAT HE WAS EXPERIENCING SOME IRRITATION AND BLISTERING ON THE INSIDE OF HIS CHEEK, INDICATING A POSSIBLE ALLERGIC REACTION TO THE ORATECT DEVICE. THE PATIENT WAS MONITORED FOR SEVERAL MINUTES AND THE TESTING STAFF NOTED THAT NO FURTHER SYMPTOMS OCCURRED. THE PATIENT WAS THEN RELEASED, AND DID NOT SEEK FURTHER MEDICAL ATTENTION. REPEATED ATTEMPTS TO GATHER LOT NUMBER INFORMATION FROM THE CUSTOMER WERE MADE ON (B)(6), 11TH, 12TH, 13TH, 19TH, 20TH, AND 24TH, HOWEVER THE CUSTOMER WAS UNABLE TO CONFIRM THE LOT OF PRODUCT INVOLVED IN THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768882 | ALERE ORATECT | ORATECT ORAL FLUID DRUG SCREEN DEVICE | DJC | AMEDITECH, INC. | ORATECT III |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |